The Ombu Library has a new article on setting the lifetime of a medical device. This includes issues related to record retention and to risk management. Look in the Medical Device Regulations section.

On June 4, 2013, Dan O’Leary will join a panel of other experts to discuss the UDI Rule and what it means to device manufacturers. The panel discussion is part of the Tenth Annual Medical Device Quality Congress sponsored by FDA News. http://www.fdanews.com/conference/detail?eventId=3232

There is a new article in the Ombu Library, in the Medical Device Regulations Section, on the timing of the UDI final rule. FDA plans to issue it by June 30, 2013, but some members of Congress believe the law requires a publication date before May 7, 2013.

FDA’s Center for Devices and Radiological Health (CDRH) offers online courses to help medical device manufacturers. The list below includes the complete list of courses in English, including some recently updated. The URL for the courses is http://www.fda.gov/Training/CDRHLearn/ucm162015.htm

Course List

• Overview of Regulatory Requirements: Medical Devices [Updated 11/29/2011]
• Guidance Documents and Standard Operating Procedures (SOPs) [Updated 04/10/2012]
• Premarket Notification Process - 510(k)
• Investigational Device Exemption Process - IDE [Updated 2/23/2012]
• Bioresearch Monitoring (BIMO) [Updated 2/23/2012]
• Device Establishment Registration and Listing
• CDRH Regulated Software: An Introduction
• Quality System Regulation 21 CFR Part 820
• Medical Device Recalls [Updated 2/23/2012]
• Medical Device Reporting (MDR)
• Export Certificates for Medical Devices
• Regulation of Radiation-Emitting Products
• Global Initiatives [Updated 03/23/2012]
• Medical Devices in the Home

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 - Premarket Evaluation
SG2 - Post-Market Surveillance/Vigilance
SG3 - Quality Systems
SG4 – Auditing
SG5 - Clinical Safety/Performance
AHWG - Global Model
AHWG - Unique Device Identification
AHWG - Regulatory Change Management

In February 2012, GHTF issued a draft guidance document as listed below

SG5 - Clinical Safety/Performance
SG5(PD)/N8R3 Clinical Performance Studies for In Vitro Diagnostic Medical Devices
The comment period ends June 2, 2012

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

The International Medical Device Regulatory Forum (IMDRF) held its inaugural meeting from February 28 to March 1, 2012 in Singapore. Regulators from Australia, Brazil, Canada, Europe, Japan, and the US attended the meeting. It also included observers from China, the Russian Federation, and the World Health Organization (WHO).

The meeting took steps to transition several key items from the Global Harmonization Task Force (GHTF) by the end of 2012. In addition, they created a list of work items:

• Review the NCAR Exchange Program
• A roadmap for implementation of a UDI system
• Developing a medical device single audit program
• Create a list of international standards recognized by members
• Develop a messaging standard for electronic transmission of regulatory submissions

The forum’s web site is www.imdrf.org

On March 19, 2012 FDA issued a guidance document setting up the program for voluntary submission of ISO 13458 audit reports. See UCM212798. By submitting two years of acceptable ISO 13485 audit reports, FDA can remove the firm from the routine inspection work plan for one year. Current law requires an FDA inspection for Class II and Class III device manufacturers once in every two-year period.

A device manufacturer can participate under the following conditions

• The firm submits the audit report within 90 days of the audit
• The audit uses ISO 13485:2003
• The auditor is under the regulatory system of Canada, the European Union, Australia, or Japan

The firm submits two years of documentation including the audit report, any related correspondence or communication, and a copy of the ISO 13485 certificate. The documentation must be PDF files submitted electronically through the “FDA eSubmitter” system.

One quandary a Quality Engineer faces is the selection of a sampling distribution to model a particular problem. Often, this depends on characteristics of the problem. The paper, Selecting Discrete Sampling Distributions explains how to select the right distribution. The paper uses a flow chart, with some question, to lead the user to the right distribution. The paper also contains a short explanation of each distribution and an example.

 

A subsequent paper examines the methods to describe discrete distributions such as the probability mass function, the mean, the variance, etc. In addition, other papers provide detailed explanations of each distribution.

 

Readers can find the articles in the Statistical Distributions section of the Ombu Library.

With the increased interest in Unique Device Identification (UDI) the Global Harmonization Task force (GHTF) issued a guidance document on developing a UDI that will satisfy international concerns. When a regulatory authority (such as a region or a country) develops a UDI system it will, when implemented, achieve a globally harmonized approach by following the principles in the GHTF guidance.

 

The guidance defines a UDI compromised of a Device Identifier (DI) and a Production Identifier (PI). The DI is a unique code specific to a model or version of a device, while the PI includes serial number, lot or batch number, expiration date, etc.

 

Under the guidance, a UDI System has three parts: a UDI developed to a global standard, application of the UDI to the device, and information in an accessible UDI database.

 

While the GHTF organization is principally by Study Groups, it also has Ad Hoc Working Groups. One of these, UDI Ad Hoc Working Group, issued the guidance document GHTF/AHWG-UDI/N2R3:2011 entitled Unique Device Identification (UDI) System for Medical Devices and issued on September 16, 2011.

 

The US has a UDI program operating in FDA. The President signed the law requiring UDI on September 27, 2007. The FDA has not issued UDI regulations.

ISO 13485:2003 clause 7.2.1 has specific expectations of the organization to determine product requirements. This article explains the requirements and provides examples. It also states the linkage to design inputs.

The GHTF issued the following statement (corrected for grammar and spelling).

 

“On Oct 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan, and United States, as well as the World Health Organization (WHO), met in Ottawa to address the establishment and operation of a new organization, the International Medical Device Regulators Forum (IMDRF). This Forum will accelerate international medical device regulatory harmonization. The Forums Management Committee, composed of regulatory officials, will provide guidance on strategies, policies, directions, membership, and activities. Furthermore the Management Committee will oversee Ad Hoc Working Groups which may draw upon expertise from various stakeholder groups such as industry, academia, health care professionals, and consumer and patient groups. The IMDRF will meet bi-annually with the inaugural meeting taking place in Singapore from February 28th, to March 1st, 2012 under the leadership of Australia. As part of these bi-annual meetings stakeholders will have an opportunity to learn of the work of the Forum, provide input on emerging issues and suggest potential new work items.”

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

 

SG1 - Premarket Evaluation

SG2 - Post-Market Surveillance/Vigilance

SG3 - Quality Systems

SG4 – Auditing

SG5 - Clinical Safety/Performance

AHWG - Global Model

AHWG - Unique Device Identification

AHWG - Regulatory Change Management

 

In October 2011 GHTF issued some documents of interest described below.

 

SG1 - Premarket Evaluation

SG1(PD)/N078R03 Principles of Conformity Assessment for Medical Devices (Draft)

This document, when approved, supersedes GHTF/SG1/N40:2006 which provided guidance on the same topic. 

SG1(PD)/N077R04 Principles of Medical Devices Classification (Draft)

This document, when approved, supersedes GHTF/SG1/N15:2006 which provided guidance on the same topic.  It has been modified to:

·        clarify the basis of allocating medical devices to one of four classes;

·        change the rule applying to sterilisation and disinfection devices;

·        remove the inconsistency with GHTF/SG1/N011 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED);

·        add a Section on the reclassification of medical devices; and

·        incorporate changes resulting from the public scrutiny process. 

 

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

The article explains how to clarify definitions and terms. It starts with an understanding of the specific vocabulary in a standard such as ISO 13485:2003. This standard applies to medical devices and includes some specific terms from that file. In addition, it also incorporates, by reference, technical terms in ISO 9000:2005.

 

The article explains the role of ISO 9000:2005 and explains how it organizes terms and provides diagrams that help improve understanding.

 

In addition, the article explains the role of an ISO guidance document that provides definitions of common terms used in the family of standards.

 

The article uses an example, from the requirements for customer supplied property, that illustrates using the various terms to help satisfy the requirement in a QMS

FDA’s Center for Devices and Radiological Health (CDRH) published a list of guidance documents it intendeds to develop in Fiscal Year 2012 (FY12). Each year CDRH publishes a list and invites comments including draft language on the proposed topics and/or suggestions for new or different guidance documents. Submit electronic comments to http://www.regulations.gov at docket FDA-2007-N-0270.

 

The list includes:

510(k) Issues

• 510(k) Modifications
• 510(k) Paradigm (510(k) Program Guidance)

 

Medical Device Classification

• Medical Device Classification Product Codes

 

Medical Device Reporting

• Distinguishing and Reporting Medical Device Recalls from Product Enhancements
• Medical Device Reporting
• Electronic Medical Device Reporting

 

Standards

• Appropriate Use of Consensus Standards in Premarket Submissions
• Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

 

Laboratory Developed Tests

• Framework for Regulatory Oversight of Laboratory Developed Tests
• FDA Notification and Medical Device Reporting for Laboratory Developed Tests
• Quality System Requirements Guide for Laboratory Developed Tests

 

The full list of proposed guidance documents is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm

 

 

Medical device manufacturers validate Excel spreadsheets. However when the version changes, from Excel 2003 to Excel 2007, for example, companies face a new set of issues. This is particularly important if some employees are on Excel 2003 and other on Excel 2007.

 

The article illustrates the problem using a simple example that relies on Conditional formatting used to track calibration status. The article, Excel Spreadsheet Validation with Multiple Versions is in the Medical Device Regulations section of the library.

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 - Premarket Evaluation

SG2 - Post-Market Surveillance/Vigilance

SG3 - Quality Systems

SG4 – Auditing

SG5 - Clinical Safety/Performance

AHWG - Global Model

AHWG - Unique Device Identification

AHWG - Regulatory Change Management

 

In September, 2011 GHTF issued some documents of interest described below.

 

SG1 - Premarket Evaluation

Label and Instructions for Use for Medical Devices (Final)

 

SG5 - Clinical Safety/Performance

Clinical Evidence for IVD Medical Devices – Key Definitions and Concepts (Proposed)

Clinical Evidence for IVD Medical Devices – Scientific Validity Determination and Performance Evaluation (Proposed)

 

AHWG - Unique Device Identification

Unique Device Identification (UDI) System for Medical Devices (Final)

 

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

 

 

Health Canada issued a new guidance document entitled Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application

 

This guidance, effective November 1, 2011, covers medical device licence applications and medical device licence amendment applications for both Class III and Class IV in vitro diagnostic devices (IVDDs) and non-IVDDs (medical devices). Therefore, as of November 1, 2011, all premarket review documents for Class III and Class IV medical device licence applications and licence amendment applications will be expected to be submitted in both paper and electronic formats and be structured and prepared using the specifications outlined in this notice.

 

The new guidance document refers to Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications published October 23, 1998 (http://www.hc-sc.gc.ca/dhp-mps/mdim/ applic-demande/guide-ld/prmkt2_precomm2-eng.php). together, they form the basis for submissions, but Sections 1.0 to 4.0 of the electronic folder structure differ from the paper-based guidance due to reorganization, however, no new content or forms are required.

 

You can obtain a copy of the new guidance from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.pdf

 

 

The Ombu Library contains a brief article on the role of harmonized standards in compliance to the Medical Device Directive (MDD). The article explains the use of harmonized standards to satisfy the Essential Requirements in Annex I.

The EU updated the list of MDD Harmonized Standards on August 19, 2011.

 

The two most commonly cited standards did not change.

 

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

 

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

Some of the items marked new include:

• Parts of EN ISO 13408 Aseptic processing of health care products
• Parts of EN 13976 Rescue systems - Transportation of incubators

 

You can read the full list of harmonized standards at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

 

An article that helps clear up the confusion between corrective action and preventive action is in the Ombu Library. Many people fall into the “language trap” because they want to prevent a detected problem from happening again. Unfortunately, this does not agree with the definitions in ISO 9000 family of quality management standards. In that family there is a distinction between a detected nonconformity and a potential nonconformity which carries over into corrective action and preventive action. The article explains the difference between preventive action and corrective action and illustrates the difference with examples.

 

You can read the article in the CAPA Systems section of the library.

 

In a Federal Register Notice published August 1, 2011 [Docket No. FDA-2011-N-0542], FDA set the rates for medical device user fees. The rates include a standard fee and a fee for small business. A company with no more than $100 million in sales in the most recent tax year may qualify for the reduced small business fee. A business with gross sales of no more than $30 million may also qualify for a waiver of the fee for the first premarket application (PMA, PDP, or BLA) or premarket report.

 

The table below shows the FY 2012 fee schedule.

 

On July 27, 2011 FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issues a draft guidance document on when to submit a 510(k) for a change to an existing device.

 

This draft guidance is one of 25 specific actions that FDA intends to improve the premarket review programs. When issued, the guidance will replace the 1997 version, Deciding When to Submit a 510(K) for a Change to and Existing Device.

 

Among the drivers for change include the Quality System Regulation (QSR), issued after the 1997 guidance, software issues, and other rapidly changing technologies.

 

The 1997 version uses a decision process driven by a set of flowcharts. The draft guidance eliminates the flowcharts, but uses a large number of examples to illustrate the principles.

 

The guidance documents help manufacturers to implement 21 CFR §807.81(a)(3). That require a 510(k) submission when:

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

 

(ii) A major change or modification in the intended use of the device.

 

The draft guidance addresses the following areas:

·        Manufacturing Process Changes

·        Labeling Changes

·        Technology, Engineering, and Performance Changes

·        Materials Changes

·        Is Clinical Data Necessary to Determine Substantial Equivalence?

 

The draft guidance document stresses that the manufacturer should not evaluate each change alone, but in context with any earlier changes. The idea is to compare the device, after the proposed change, with the current cleared 510(k) for the device. This ensures that the proposed change includes the cumulative impact of all changes.

 

Each section, except the last, includes a series of questions, explanations, and example. For example, Technology, Engineering, and Performance Changes asks, “Is it a change in energy type?” the explanation includes, “Energy type refers to the type of power input to or output from the device.” The example tells us “A device that is changed from an external power source to battery power should result submission of a new 510(k).”

 

You may get a copy of the draft guidance using the search engine at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

 

You may comment on the draft through [FR Doc No: 2011-18923] at http://www.regulations.gov.

MIL-STD-1916 contains the Department of Defense (DoD) preferred method for product acceptance. It seeks process control and statistical control methods, but does provide sampling inspection plans for lot acceptance by attributes. The article describes the plans. It explains the concept of AQLs and describes some of the reasoning why the standard uses verification levels instead. The article also provides some examples to determine the sampling plan.

 

You can read the article in the Acceptance Sampling section of the library.

The Global Harmonization Task Force (GHTF) recently posted two new documents.

 

The GHTF Steering Committee posted a final document entitled "Definition and Glossary of Terms Used in GHTF Documents". This document has a list of the definitions used in GHTF final documents. By consolidating the definitions into a single list, GHTF produced a useful Glossary of Terms.

 

GHTF Study Group 2 (Post-Market Surveillance/Vigilance) and Study Group 5 (Clinical Safety/Performance) published a proposed document for comment. The document is entitled “Reportable Events During Pre-Market Clinical Investigations” and is open for comment until December 10, 2011. The document is intended as a global model to provide guidance on the types of adverse events to report to National competent Authorities when conducting clinical investigations. The proposed document also utilizes ISO 14155:2011 Clinical Investigations of medical devices for human subjects – Good clinical practice.

 

Note that as of July 3, 2011

• ISO 14155 is not an FDA recognized consensus standard.
• ISO 14155:2011 is not harmonized to the MDD (but the earlier version is.)

The recast Restriction on Hazardous Substances (RoHS) (Directive 2011/65/EU) appeared in July 1, 2011 edition of the Official Journal of the European Union. The recast directive now includes medical devices that are also electrical and electronic equipment.

 

The directive applies to medical devices placed on the market after July 22, 2014 and in vitro diagnostic devices placed on the market after July 22, 2016. The directive does not apply to active implantable medical devices.

 

A manufacturer prepares technical documentation demonstrating that design and manufacture of the product satisfies the requirements of the RoHS directive. The manufacturer prepares a declaration of conformity (Annex VI specifies the required elements) and retains both documents for ten years after placing the product on the market.

 

The limits in the directive create maximum concentration value by weight in homogeneous materials. Annex II lists the materials and their limits. Annex IV lists some medical device applications exempt from the restrictions.

Lead 0.1%

Mercury 0.1%

Cadmium 0.01%

Hexavalent chromium 0.1%

Polybrominated biphenyls (PBB) 0.1%

Polybrominated diphenyl ethers (PBDE) 0.1%

 

You can download the directive from the Official Journal at

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2011:174:SOM:EN:HTML

The EU updated the list of MDD Harmonized Standards on May 13, 2011.

 

The two most commonly cited standards did not change.

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

Some of the items marked new include:

EN ISO 8835-3:2009/A1:2010 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

 

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

 

EN 60601-2-52:2010 Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

 

The list of harmonized standards is available at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Health Canada issued three new guidance documents in June 2011.

·        Guidance Document For The Interpretation Of Significant Change

·        Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices

·        Guidance On The Content Of Quality Management System Audit Reports

 

You can download the documents from http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

 

The significant change guidance uses a series of flow charts to help the user classify changes. The guidance document has a main flowchart that leads to others as listed below.

 

Main Flowchart: General changes made to devices

Flowchart A: Changes in manufacturing processes, facility or equipment

Flowchart B: Changes in manufacturing quality control procedures

Flowchart C: Changes in design

Flowchart D: Changes to sterilization

Flowchart E: Changes to software

Flowchart F: Changes in materials for non in vitro diagnostic devices (IVDDs)

Flowchart G: Changes in materials for IVDDs

Flowchart H: Changes to labeling

 

The reusable device guidance explains how the regulations apply to each class of device. The guidance provides a table format, based on CAN/CSA/ISO 17664, for reprocessing instructions.

 

The audit report guidance contains information on the preparation and content of QMS audit reports. This guidance uses work of the Global Harmonization Task force (GHTF) Study Group 4, in particular, SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

 

The guidance also supports the US FDA’s Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

The Risk Priority Number (RPN) is a method to allocate resources. The article discusses the risk management approach of assigning risk acceptability based on severity and probability. In contrast, the FMECA, a reliability tool, often uses the RPN on a scale of 1 to 1,000. The article explains the role of the RPN and shows that there are only 120 possible values, not the 1,000 as commonly expected.

In May of this year, the US Supreme Court handed down a unanimous decision that linked adverse reporting to the FDA with financial reporting. Matrixx had information concerning potential problems with Zicam Cold Remedy, the largest selling product in their line. They didn’t reveal the adverse event information to investors because they didn’t find the information statistically significant. The Court concluded that statistical significance is not the threshold for reporting.

 

The article, published in Cerulean’s Smarter Compliance^TM is available in the Ombu Library. This newsletter is a valuable resource for people involved FDA regulatory issues. I recommend that readers subscribe to this valuable newsletter. To subscribe, send an e-mail to orders@ceruleanllc.com or visit www.ceruleanllc.com.

 

Readers may recognize Cerulean by its association with John Avellanet and his influential book Get To Market Now! This book, describing the methods you need to help turn FDA compliance into a competitive edge, belongs in the “most frequently read” section of your book shelf.

The Global Harmonization Task Force (GHTF) issued a new guidance document on a regulatory model. The guidance diagrams a model, from a few different views, and shows how the guidance documents from the GHTF’s Study Groups fits into the model. While starting with a simple life-cycle model for devices, the guidance refines it into a more comprehensive approach, showing how each GHTF Study Group’s documents fit into the refined model.

 

The document includes tables that delineate the role and responsibility of some stakeholders in the regulatory system, i.e., manufacturers, regulators, and conformity assessment bodies. The guidance also includes a bibliography of GHTF and ISO documents that factor into the regulatory scheme.

 

Readers may obtain the document from the GHTF website (www.ghtf.org) or from the Ombu Library.

In January 2011 the FDA launched a new website, “to help companies and others save time and resources in their interactions with the agency.” The new website is available at http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm

 

The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that industry frequently requests.

 

The website is part of the transparency initiative and is one of the 19 action items listed in the FDA’s report titled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.”

 

The menu bar, at the left of the opening page has the following selections:

About FDA

Guidances

Registration and Listing

Regulatory Process

Product Application and Petition Review Process

Stay Informed

Search Databases

Popular Content

Frequently Asked Questions

Educational Resources

On March 14, 2011 the FDA issued Updated Recognition List #26. Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

 

This new recognition list updates previous recognitions and identifies other standards recognized for the first time.

 

The announcement breaks the recognized standards into the categories listed below.

 

Anesthesia

Biocompatibility

Cardiovascular

Dental/ENT

General

General Hospital/General Plastic Surgery

IVD

Materials

Nanotechnology

OB-GYN/Gastroenterology

Ophthalmic

Orthopedics

Physical Medicine

Radiology

Software/Informatics

Sterility

Tissue Engineering

The list is available at http://www.gpo.gov/fdsys/pkg/FR-2011-03-14/html/2011-5815.htm

The EU updated the list of MDD Harmonized Standards on January 18, 2011.

 

The two most common standards did not change.

 

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

 

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

The EU publishes the list at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Health Canada released a draft guidance document on the content of QMS audit reports. The document is open for comments until March 8, 2011. The document provides guidance to Health Canada recognized registrars on the content of quality management system (QMS) audit reports.

 

This guidance document uses the work of Study Group 4 of the Global Harmonization Task Force (GHTF), and in particular on the technical content of GHTF document SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

You see the announcement, learn how to comment, and get a PDF copy of the draft guidance at http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/draft_ebauche_md_im_gd211-eng.php

The European Commission issued two new guidance documents on Clinical Investigations. MEDDEV 2.7/4 provides Guidelines on Clinical Investigations: A Guide for Manufacturers and Notified Bodies.

 

The basis for the guidelines SG5/N3:2010 Clinical Investigations posted on April 26, 2010 (see www.ghtf.org). The MEDDEV guidance is adapted to the requirements in Annex X of the Medical Device Directive (MDD). A manufacturer should conduct Clinical Investigation following the guideline. A clinical investigation, in MEDDEV 2.7/4, is “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.” (SG5/N1:2007)

 

MEDDEV 2.7/3 Clinical Investigations: Serious Adverse Event Reporting provides information on reporting adverse events occurring in clinical investigations. The website also provides an Excel form for reporting.

 

You can download these new guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/

In December 2010 Health Canada added some new information on how it regulates software that is a medical device. The Notice says, “Software that is intended or represented for use in the diagnosis or treatment of an abnormal physical state of a patient meets the definition of a medical device under the Food and Drugs Act and must therefore comply with the requirements of the Medical Devices Regulations.”

 

The two documents, posted on Dec. 12, 2010, are:

Software Regulated as a Medical Device - Frequently Asked Questions

Notice - Software Regulated as a Class I or Class II Medical Device

 

You can read the documents on the Health Canada website

http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

The Ombu Library has a new document, in the Medical Device Regulations section, that lists the changes to FDA’s Quality System Regulation. FDA issued the final rule on Oct. 7, 1996. Since then, QSR changed seven times. FDA has changed only three sections since they issued the final rule:

21 CFR §820.1 Scope

21 CFR §820.198 Complaint files

21 CFR §820.200 Servicing

 

The summary identifies the sections affected, lists the changes, and provides the citation in the Federal Register.

The Global Harmonization Task Force (GHTF) is a voluntary international organization that supports harmonization of medical device regulations around the world. GHTF has five study groups, who issue guidance documents. Study Group 3 (SG3) covers issues related to Quality Systems.

 

The new guidance, Quality Management Systems – Medical Device – Guidance on Corrective Action and Preventive Action and Related QMS Processes id dated Nov. 2010 and is the final version of the document.

 

The document doesn’t use the acronym “CAPA” since “the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.”

 

The guidance partitions the corrective action and preventive action processes into four phases: Planning, Measurement and Analysis, Improvement, and Input to Management. The guidance illustrates each phase and the linkages with an overview diagram. In addition, the guidance each phase and it constituent processes.

 

In Phase I, Planning, the manufacturer specifies the processes and resources needed to meet the objectives. This phase plans for measurements and analysis and establishes data sources.

 

Phase II conducts measurement, monitoring, and analysis to determine conformity and nonconformity.

 

Phase III, the Improvement phase helps mitigate or eliminate the cause of a detected or potential nonconformity. This phase uses a six step process:

1. Investigate

2. Identify Root Cause

3. Identify Actions

4. Verification of Identified Actions

5. Implement Actions

6. Determine Effectiveness of Implemented Actions

 

Phase IV reports to Management. The Management Review helps management ensure the overall QMS is effective.

 

You download this GHTF guidance document, at no charge, from www.ghtf.org/sg3/sg3-final.html. The GHTF web site is www.ghtf.org which gives access to the documents from all the Study Groups.

At a recent FDA News conference I asked Kimberly Trautman, FDA’s expert on QSR, if FDA has any plans to update QSR based on the changes to ISO 9001 and ISO 13485. QSR dates from the element approach (in ISO 9001:1994), but the ISO standards now employ the process approach. Her answer surprised me. FDA may consider updating QSR after the next round of changes to ISO 9001 and ISO 13485. She explained that ISO plans extensive changes in 9001 for 2014 or 2015. Moreover the new version of 13485 must reflect the changes in 9001. She said that the 9001 changes may include many of the techniques employed in the automotive industry, meaning that will also be in a subsequent 13485 revision and applied to the medical device industry.

 

The planning process for ISO 9001 is underway. ISO/TC 176, who is responsible for ISO 9001, is soliciting input with a survey. Recognizing the link between 13485 and 9001, you should take the survey. The link is http://isotc.iso.org/livelink/livelink/fetch/2000/2122/-8835176/-8835848/8835872/8835883/9841934/customview.html?func=ll&objId=9841934&objAction=browse

 

While the survey is broad it asks some very interesting questions. One relates to format and asks the respondent about the format. The choices are:

 

Option A - Leave ISO 9001 unchanged – re-confirm “as-is” for a future five years (to approximately 2018).

 

Option B - Revision of ISO 9001 - based on the suggestions for change given in this survey, produce one revised ISO 9001 standard, where all requirements remain equally mandatory.

 

Option C - Leave ISO 9001:2008 unchanged but also develop another standard with an enhanced (higher level) set of Quality Management System requirements for sustained success that can be used for certification/registration.

 

Option D - Leave ISO 9001:2008 unchanged but also develop another standard with a reduced (lighter version) set of requirements that can be used for certification/registration of organizations providing low-risk products.

 

Option E - Replace ISO 9001:2008 with a series of three documents (Quality Management System 1, Quality Management System 2, Quality Management System 3) with higher, middle and lower set of requirements that can be used for certification/registration depending on the risk and criticality associated with the organization’s products.

 

Option F - Replace ISO 9001:2008 with a single standard, that would include a much broader range of higher and lower sets of requirements, allowing organizations a greater choice depending on risk and criticality associated with the organization’s products.

 

Option G - Replace ISO 9001:2008 with a single standard including a full range of higher, middle and lower sets of requirements, with points-based maturity assessment.

 

In addition, there is a question about the techniques to include. The choices here are:

• Supporting Quality Tools (for example Six Sigma, Lean, Statistical Process Control)
• Financial resources of the organization
• Innovation
• Integration of Risk Management
• Knowledge Management
• Life Cycle Management
• Strategic Planning
• Measures (examples are performance, satisfaction, return on investment) Measures (examples are performance, satisfaction, return on investment)
• Systematic problem solving and learning
• Voice of the Customer
• Use of technology to develop and implement the requirements of the standard
• Use of technology to run your business
• Self-assessment tool

 

The survey gives a link to an explanation of the concepts.

http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/8579854/customview.html?func=ll&objId=8579854&objAction=browse&sort=name

 

FDA’s QSR defines two terms that often confuse practitioners: component and manufacturing material. QSR defies these terms but confusion continues. This Ombu paper explains these terms and others as well. The broad term “product includes five things: component, manufacturing material, in=process device, finished device, and returned device. The paper discussed each of them and explains the differences and the requirements for each one.

 

You can read the paper Understanding Product in FDA’s QSR in the Medical Device Regulations section of the Ombu Library.

CDRH offers courses in medical device topics at their website http://www.fda.gov/Training/CDRHLearn/default.htm

 

CDRH recently added two news courses:

Export Certificates for Medical Devices

Medical Device Reporting (MDR)

 

The MDR course includes separate modules on:

MAUDE - Information Available to the Public

Electronic Medical Device Reporting (eMDR)

Medical Device Reporting

MDR for User Facilities

MDR for Manufacturers and Importers

 

All of the courses offer a video program or just the slides to download. Many of the courses also offer a post course test to help you evaluate your learning.

Canada recently published a clarification of device labeling. The new approach applies only to devices not sold to the general public.

 

The manufacturer may provide electronic labeling on a Compact Disc (CD) or Digital Video Disc (DVD), that accompanies the device at the time of sale and/or delivery. The CD or DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on the CD or DVD should be easily navigable.

 

In addition, for Class IV devices and in vitro diagnostic devices (IVDD) that are not near patient IVDDs may provide the labeling information on the internet. The devices must include the internet address and be displayed to alert the user.

 

You may find more information at http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_e-labelling_im_etiquetage_electronique-eng.php

A new paper on statistical tolerancing is new in the Ombu Library. This paper explains some basic concepts of statistical tolerancing and contrasts the method with worst case analysis.

 

The simplifying assumptions include a normal distribution and a Cpk = 1.00 for both the parts and the final assembly. The paper explains the method to combine normal distributions to model the resultant distribution.

CDRH recently announced the completion of a pilot program with Health Canada (HC) to perform joint inspections.

 

The pilot inspected 10 companies, who volunteered for the program. The inspectors were in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices conformity Assessment System (CMDCAS). One of the pilot project’s goals was to determine the potential for time savings in the inspection process. This would benefit FDA, HC, and the site under investigation. The pilot showed savings of about 35% in person-days to conduct the inspection.

 

The final joint report, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm232806.htm, describes the results of the project.

 

The final report lists findings and recommendations. We describe a few of them below.

 

The activity types should align. The activity should pair HC surveillance with FDA Level 1; pair HC re-assessment and FDA Level 2.

 

Nonconformity responses didn’t contain a cause analysis, a clear statement of the correction, or a clear statement of the corrective action. As a result, both HC and FDA intend to train inspectors using the Global Harmonization Task Force guidance GHTF/SG3/N18 “Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes”. See www.ghtf.org.

 

Reports varied in description, level of detail, and format. They varied in length from 3 to 20 pages. FDA and HC are collaborating on a single report format developed in HC “GD 211: Guidance on the content of quality management system audit reports”.

Each year CDRH publishes a list of proposed new documents for the upcoming fiscal year. CDRH published the FY11 list on Oct. 6, 2010.

 

Some the proposed documents are in the list below.

 

Guidance on Postmarket and Compliance Issues

Medical Device Reporting for Manufacturers

"510k Actions"-FDA and Industry Actions on Premarket Notification Submissions

Research Use Only

Distinguishing Medical Device Enhancements from Product Recalls and Corrections

Electronic Medical Device Reporting

 

Global Harmonization or Standards Related Guidances

Global Harmonization Task Force: Quality Management System; Process Validation

Global Harmonization Task Force: Post Market Surveillance; National Competent Authority Report Exchange Criteria and Report Form

Application of IEC 60601-1 Third Edition

Medical Device ISO 13485

 

Cross-Cutting, Process, and Other Guidances

Radio-Frequency Wireless Technology in Medical Devices

Quality Systems for Laboratory Developed Tests

Medical Device Home Use

 

You may view the complete list at  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm

 

Health Canada issued the draft guidance for comment. This guidance, for Class III and Class IV devices, uses the Global Harmonization Task Force (GHTF) approach to documentation.

 

The GHTF developed the Summary Technical Documentation (STED) approach to encourage and support convergence of regulatory systems for medical devices among jurisdictions. Health Canada has adopted use of the STED for premarket license applications and license amendment applications for Class III and Class IV medical devices. Although the use of the STED is not mandatory, Health Canada strongly encourages manufacturer’s to follow this guidance when submitting Class III and IV medical device license applications and amendment applications.

 

The comment period ends on December 12, 2010.

 

You can obtain a copy of the draft guidance and information on submitting comments at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/md-im/md_draft_gd_im_ebauche_ld_sted-eng.pdf

 

The Global Harmonization Task Force (GHTF) published two new guidance documents in their quality auditing series.

 

GHTF/SG4/N83:2010 is part 4 and deals with Multiple Site Auditing

 

GHTF/SG4/N84:2010 is part 5 and deals with Audits of Manufacturer Control of Suppliers

 

Both documents are available at no charge from www.ghtf.org.

 

The final documents in the series cover the following topics.

Part 1: General Requirements

Part 1 Supplement 2: Training Requirements for Auditors

Part 2: Regulatory Auditing Strategy

Part 3: Regulatory Audit Reports

Part 4: Multiple Site Auditing

Part 5: Audits of Manufacturer Control of Suppliers

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. The TPLC database is refreshed as each of the individual data sources is updated.

 

The TPLC database description is at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm199906.htm

 

From this link, the user can move to the search page where you can search the TPLC database by device name, product code (the 3 letter code for each device), or regulation number. The search provides a full report about a particular product line.

CDRH announced a database for certain inspections. The inspections in the database are limited to those for which CDRH had direct involvement. In general, FDA’s Office of Regulatory Affairs (ORA) conducts device inspections. CDRH becomes involved in inspections such as foreign inspections, Medical Device Reporting (MDR) malfunction issues, labeling, and software issues.

 

You can search the Inspection database by Company Name, Country, Medical Specialty, Inspection Type, Product Code, Inspection Classification, Inspection Action, District, or Date. The database has the following URL.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/inspect.cfm

This program introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.

Both ISM and APICS offer certifications in Supply Chain Management. The ISM certification is Certified Professional in Supply Management (CPSM). The APICS certification is Certified Supply Chain Professional (CPSC). Ombu performed a comparative analysis between the certifications including requirements to take the exam, exam content, total certification cost, and certification maintenance. Ombu presented the analysis to NAPM-NH as part of a workshop on professional certification.

One of the issues in Total Productive Maintenance (TPM) is the calculation of equipment utilization. This article explains the calculation using the standard method developed in the TPM literature. However, it offers a much more intuitive explanation by explicitly looking at time as the measurement parameter. Look for this article in the Total Productive Maintenance section.

The European Union publishes guidance documents for medical devices. These guidance documents provide valuable information for companies that supply medical devices subject to the Medical Device Directive (MDD), 93/42/EEC as amended by Directive 2007/47/EC.

 

The EU publishes the guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines

 

In June 2010, the EU published revision 9 of MEDEV 2.4/1 Classification of Medical Devices.

 

This document is a revision of an earlier document published in July 2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to the changes in classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001, including derogation of the classification rules in the case of breast implants and hip, knee and shoulder joint replacements and requirements related to devices containing human blood derivatives and medical devices manufactured utilizing tissues of animal origin. In addition this guidance document takes account of the changes arising from Directive 2007/47/EC which further amends Directive 93/42/EEC and became applicable as from 21st March 2010.

Occasionally, firms need information on the EU’s RoHS Directive. Ombu has answered some client questions, and provides a simple Q&A that can help a firm get started.

The FDA publishes Guidance Documents, following 21 CFR §10.115, to provide information for stakeholders.

• Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agencys interpretation of or policy on a regulatory issue.
• Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.
• Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.

 

CDRH staff, regulated industry, and the public prepare Guidance Documents related to:

• the processing, content, and evaluation of regulatory submissions
• the design, production, manufacturing, and testing of regulated products
• the inspection and enforcement procedures

 

FDA published a comprehensive list, organized by Center, in the Federal Register on August 9, 2010.

 

For devices, you can search CDRH guidance documents at

 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

 

The US Government’s Paperwork Reduction Act requires Federal Agencies to report collection activities to the Office of Management and Budget for approval and renew the approval every three years.

 

FDA is seeking public comments on the collection activities related to QSR. The FDA published the notice in the Federal Register as Docket Number FDA-2010-N-0273. You can get a copy and offer comments at http://www.regulations.gov/search/Regs/home.html#home

 

FDA estimates that there are 8,924 firms that must collect information, and that the total number of hours to write and maintain procedures, generate records, etc. The Federal Register Notice describes the activities under the various QSR sections and subsections and estimates the hours per record. For example, “Section 820.22 requires the conduct and documentation of [Quality System] audits and reaudits.” FDA estimates that a firm subject to QSR needs 33 hours per year to satisfy section 820.22.

 

Ombu commented on the proposed recording keeping requirements, because we believe the estimates are very low. The notice and Ombu’s comments are in the Ombu Library in the FDA Information Section.

Dan O’Leary will present a half-day workshop on supplier agreements at the 2^nd Annual Supplier Summit sponsored by FDA News. The workshop is part of the pre-conference activities, and is scheduled for August 18 in Bethesda, MD

 

For information on the conference, see the brochure at

http://www.fdanews.com/conference/detail?eventId=2919

The consultation process seeks public views related to a legislative proposal that addresses:

 

·        Classification of IVDs

·        Conformity assessment procedures applicable to IVDs

·        Scope of IVD types subject to the requirements of the IVD Directive

·        Clinical evidence for IVDs

 

The Ombu Library has a copy of the document that describes the specific issues the commission wishes to address.

 

You should submit comments by September 15, 2010.

 

Submit comments on by mail, fax, or email to:

European Commission

Health and Consumers Directorate-General (DG SANCO)

Unit SANCO B2, Cosmetics and Medical Devices

B-1049 Brussels, Belgium

Fax: 00 32 (0) 2 296 64 67

E-mail: SANCO-IVD-REVISION@ec.europa.eu

 

You can obtain further information from the European Commission website at: http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4404&tpa_id=164&lang=en

 

 

Dan O’Leary made a presentation at the FDA’s Laboratory Developed Test (LDT). The slides are on the Ombu Website in the Library section.

 

Ombu took the position that regardless of the source of the test (IVD test kit or Laboratory Developed Test) the regulatory requirements should be the same; the level playing field argument.

This note describes two of the many versions of ISO 13485. The first path describes ISO 13485, while the second path describes EN ISO 13485.

 

The ISO Path

In 2003, ISO issued ISO 13485:2003. This standard provides particular requirements for medical devices, using ISO 9001:2000 as a basis.

 

Subsequently, ISO issued ISO 9001:2008 to replace ISO 9001:2000.

 

ISO then issued ISO 13485:2003, Cor. 1 to correct some references in ISO 13485:2003. These references cite ISO 9001 without citing the version. The corrigendum clarifies the references to ISO 9001:2000.

 

The CEN Path

CEN issued EN ISO 13485:2003 as a European Norm. Eventually it became harmonized to the MDD, IVDD, and AIMDD.

 

CEN needed to replace EN 46003 and add references to Module E in several places. These modules define the conformity paths applied by the new approach directives. This change didn’t have any impact on manufacturers. The change became EN ISO 13485:2003/AC 2007.

 

CEN incorporated ISO 13485:2003 Cor. 1 and EN ISO 13485:2003/AC 2007 into EN ISO 13485:2003/AC 2009. This version is harmonized to the MDD, IVDD, and AIMDD.

 

Regards,

Dan

The list of standards harmonized to the Medical Device Directive (MDD) now includes the list of July 7, 2010 in the Official Journal.

 

Two standards of particular interest to general medical device practitioners are ISO 13485 and ISO 14971.

 

For ISO 13485, the current version is EN ISO 13485:2003/AC:2009.

 

This version is based on EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) that superseded EN ISO 13488:2000, EN ISO 13485:2000, and EN 46003:1999 on July 31, 2009.

 

For ISO 14971, the current version is EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) that superseded EN ISO 14971:2007 on March 21, 2010.

 

One can view the complete list at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

On July 19 & 20, the FDA will sponsor a public meeting on Laboratory Developed Tests (LDTs). The meeting announcement says, “Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including being developed and validated, and offered, within a single laboratory. Thus, the FDA has not actively regulated most LDTs.”

 

Dan’s presentation will be part of Session 1: Oversight of LDTs: Patient and Clinical Considerations, and will make the case that a level playing field between IVD developers and Laboratories is the best approach for public health in the US. Today, if an IVD manufacturer wishes to bring a test to market, the regulatory requirements are much higher than those experienced by a laboratory introducing the same test.

Dan O’Leary’s recently printed article in GxP Lifeline is now available in the Ombu library. This article explains some of the issues in validating medical devices and shows how to employ statistical concepts.

 

The article, “Process Validation for Medical Devices GxP Article” is in the Medical Device Regulations section.

 

The Medical Device Directive suggests the use of Harmonized Standards to assure a device meets the Essential Requirements. The EU maintains a list of these standards at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

 

The list has a new, and easier to use, format. The list clearly identifies new standards with the word (new), colored in red with a note that announces the first publication of a standard.

 

The list, at this writing, includes the information from the Official Journal dated December 2, 2009.

On April 19, 2010, Health Canada announced a list of proposed changes to recognized standards for medical device. This announcement started a 60-day comment period. Submit comments to Health Canada no later than June 18, 2010 to an address included in the proposal.

 

The proposed changes

·        Add 22 new standards

·        Recognize new versions of 92 currently recognized standards

·        Delete 31 standards

 

Included in the new versions of currently recognized standards are:

ISO 14971:2007 Medical devices - Application of risk management to medical devices

CAN/CSA-ISO 14971-07 Medical devices - Application of risk management to medical devices

 

The list does not propose any changes for ISO 13485.

 

The list of proposed changes is at

http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/md_stand_im_norm_prop_lst-eng.php

 

The current List of Recognized Standards is posted at

http://www.hc-sc.gc.ca/dhp-mps/mdim/standards-normes/md_rec_stand_im_norm_lst_2-eng.php

 

 

 

A Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations is posted at

http://www.hc-sc.gc.ca/dhp-mps/md-im/applicdemande/guideld/md_gd_standards_im_ld_normes-eng.php

 

Process validation is an important part of both FDA regulations and ISO 13485. It comes into play when a company cannot, or does not, perform 100% verification of the process output. Typically, process validation is required when the verification is destructive. The trend has shifted, however, to cases where sampling plans verify the process output.

 

This slide deck explains the fundamental requirements for process validation in both FDA QSR and ISO 13485. It explains when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports. It includes some FDA Warning Letters to help understand the requirements and explain the current status of the FDA Guidance Document as it relates to medical devices.

The Treasury Secretary issued guidance on the new Therapeutic Discovery credit. The program provides a tax credit of up to 50% of qualifying research. Eligible firms can opt for a grant, allowing start-ups not yet profitable to benefit from the program.

 

The program targets research projects with potential to produce new therapies, address unmet medical needs, reduce long-term cost growth, or advance cancer cures. The program also considers projects that create and sustain jobs or help to advance our nation’s competitiveness in life, biological, or medical science.

 

The funds are available on a competitive basis to device makers with 250 or fewer employees that have made qualified investments in qualifying therapeutic discovery projects in 2009 and 2010.

 

You may view the Treasury press release at http://www.treasury.gov/press/releases/tg712.htm

 

FDA plans to allow device manufacturers to submit ISO 13485:2003 audit results to the FDA. The program would allow FDA to evaluate the results, conduct a risk assessment, and remove the manufacturer from FDA’s routine work plan for one year.

 

The program implements one of the changes of the Food and Drug Administration Amendments Act of 2007, which allows these voluntary submissions. The law allows voluntary audit report submissions, but requires all repots during the preceding two-year period.

 

The draft guidance document requires submission of the report within 60 days from the last day of the most recent audit. The submission must include all ISO 13485:2003 audit reports issued during the preceding two-year period.

 

Docket number FDA-2010-D-0226 includes the draft guidance document and additional information published in the Federal Register. You can review and download these documents as well as comments from http://www.regulations.gov/search/Regs/home.html#home

Enter the document number in the search box.

 

The comment period on this draft guidance closes on August 18, 2010.

Based on the published schedule, Dan O’Leary will make two presentations at NEQC this year. He will present A Unified Approach to Complaints, Servicing, and FDA Reporting at 9:15 am on October 19. In addition, he will present Excel Spreadsheets and FDA Device Regulations at 3:40 pm on October 20.

 

You can learn more about the NEQC Conference at http://www.neqc.org/conference/58/

The Federal Food, Drug, and Cosmetic Act allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. FDA announced Recognition List Number 23 with the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency’s searchable database.

 

The announcement is at http://edocket.access.gpo.gov/2010/2010-10562.htm

 

The list modifies standards in the following areas: Biocompatibility, Cardiology, Dental/ENT, General, In Vitro Diagnostics, Materials, Physical Medicine, Sterility, and Tissue Engineering.

 

The list recognizes new standards in the following areas: Cardiology, In Vitro Diagnostics, Orthopedics, Physical Medicine, and Sterility.

 

An area of interest is the ISO 10993 family of standards on Biological Evaluation of Medical Devices. The table below shows the changes to this recognition status of this family.

 

 

 

 

The FDA’s Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in‑process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. FDA Warning Letters frequently cite this section of the regulations; it is in the top five sections cited.

 

This presentation explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We explain the advice offer FDA’s QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. The FDA has recommended, in Warning Letters, that manufacturer’s obtain a copy to help them come into full compliance.

 

The presentation concludes with an examination of some Warning Letters. We review some mistakes that manufacturers have made and point out ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.

The European Commission, in a recent decision, made the EUDAMED mandatory for member states starting May 1, 2011. EUDAMED is a European databank for medical devices that is required by the product directives. For example, the Medical Device Directive (MDD) Article 14a calls for the “Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well informed basis.”

 

The European Union maintains information on EUDAMED at http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm

 

Depending on the applicable directive (MDD, IVDD, or AIMD), EUDAMED contains data on:

• registration of manufacturers, authorized representatives and devices,
• data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,
• data obtained in accordance with the vigilance procedure, and
• data on clinical investigations.

 

One of the data requirements includes the use of the Global Medical Device Nomenclature (GMDN). The European standard (harmonized to the MDD and other product directives) EN ISO 15225 "Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange" describes the nomenclature requirements. The current versions are: EN ISO 15225:2000, EN ISO 15225:2000/A1:2004, and EN ISO 15225:2000/A2:2005. GMDN is maintained by the GMDN Agency, http://www.gmdnagency.com

 

EUDAMED is an information exchange between national competent authorities and the Commission and is not publicly accessible.

This presentation explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The presentation defines the concepts of accuracy and precision that describe the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.

 

Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72 and the ISO 13485/9001 requirements are in Clause 7.6.

 

Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to understanding accuracy and precision.

A company may ship a product in its final packaging to a contract sterilizer. The final packaging declares the product as sterile, but it hadn’t been sterilized yet. This potential violation could result in a misbranded product.

 

FDA regulations (21 CFR §801.150(e)) provide a control mechanism that allows this kind of shipment in interstate commerce. Under §801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following:

(1) Instructions for maintaining accountability of the number of units in each shipment;

 

(2) Acknowledgment that the devices that are nonsterile are being shipped for further processing; and

 

(3) Specifications for sterilization processing.

 

The parties must keep a copy of the agreement (21 CFR §801.150(a)(2)), for at least two years after the final shipment under the agreement. FDA Inspectors may review these records as part of an inspection.

 

Please review these regulations for the specific details. You can read the regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

 

Following the Paperwork Reduction Act, the FDA submitted information on the burden required to create and keep the records required by this part of the regulation.

 

FDA estimates that companies involved will generate the {§801.150(e)} records 20 times each year, and that each record will take 4 hours to prepare; this is a cost of 80 hours per year. In addition, the FDA estimates that record maintenance {§801.150(a)(2)} takes 0.5 hours per record; this is a total cost of 10 hours per year.

 

The total cost for these records is 90 hours per year.

Dan will present this webinar on April 23, Friday 08:00 AM PDT | 11:00 AM EDT. See http://www.complianceonline.com

 

Acceptance activities should be easy for device manufacturers. As one of the FDA’s most frequently cited sections in Warning Letters, however, there are issues and problems in this area of the regulations. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.

 

This webinar will clear up the regulatory requirements, and help you plan effective and compliant acceptance activities. We look at the regulations and explain what they mean. In addition, we look at the QSR preamble to help clarify the intent and expectations. By analyzing recent Warning Letters, you can learn from the mistakes of others, and ensure your acceptance activities fully comply with both good practice and the regulatory requirements. The Warning Letter review follows an analysis of the regulations using the QSR preamble and the guidance from FDA’s QSR Manual. We look at the process description and usage of the document.

The text of the newly enacted medical device excise tax law is now in the Ombu Library. This law, part of the Health Care and Education Reconciliation Act of 2010, defines the excise tax.

 

The tax applies to medical devices for human use, following the definition from the Food, Drug, and Cosmetics Act, except for eyeglasses, contact lenses, hearing aids, and any other medical device the Secretary of the Treasury determines is generally purchased by the general public at retail for individual use.

 

The excise tax applies to the manufacturer, producer, or importer, and is 2.3% percent of the device’s selling price. The tax applies to sales after December 31, 2012.

 

The text is in the Health Care Reform section in a document called Medical Device Excise Tax.

This article, Determining the Revision Level of QSR Sections explains how the FDA maintains sections of the regulation. Unlike standards, such as ISO 9001 or ISO 13485, the FDA changes individual sections. The article explains how to look you the revision history of any section using some tools on the FDA website. It also explains how to get the full text and other information using tools on the Government Printing Office (GPO) website.

Dan O’Leary will present a webinar for Compliance Panel on a Unified Approach to Complaints, Servicing, and FDA Reporting. Go to http://www.globalcompliancepanel.com for registration information.

 

This course provides the attendees with the information to implement an effective system for managing and reporting adverse events. We break down the regulatory requirements into plain English, and describe them using common quality tools such as flow diagrams and fault tree analysis. This approach helps you understand the essential parts of the regulations.

 

We provide complete descriptions of the interlocking systems that the FDA requires you to implement. These systems include:

·        Complaint Management

·        Medical Device Reporting

·        Corrections and Removals Management and Reporting

·        Corrective Actions

·        Corrective Action Statistical Analysis

·        Risk Management

·        Service Reports

·        Service Report Statistical Analysis

 

These requirements are spread across multiple parts of the FDA regulations, so they are not always implemented in unison. The presentation unites the systems to make their implementation easier and more effective.

 

You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, what records you must keep, and when you must report to the FDA.

 

You will see statistical techniques that can be used to analyze corrective actions and service reports. These include histograms, scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams.

 

Because these regulations may also span your organizational structure, this webinar is especially suited for cross functional and cross discipline teams.

Dan O’Leary will present a webinar for Compliance on Line on the statistical concepts that underlie process validation. Go to http://www.complianceonline.com for registration information.

 

Process validation is an important element in medical device manufacturing. This webinar looks at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.

 

When you cannot (or do not) fully verified process results by subsequent inspection and test this leads to sampling plans. We discuss the use of attribute sampling plans in this context.

 

When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. We discuss the concepts of process capability, especially the use of C_p and C_pk.

 

Operational Qualification (OQ) explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool.

 

Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

 

Background

The FDA’s Quality system regulation requires device manufacturers to validate processes when they don’t fully verify the resulting output. Based on Warning Letters, the FDA expects manufacturers to validate processes when the output check uses sampling instead of 100% inspection.

 

The requirement is to validate the process with a high degree of assurance. This, coupled with the process validation definition that a process consistently produces a result or product meeting its predetermined specifications, leads to a statistical definition. A process that consistently produces a conforming output is capable. This leads to using process capability indices, C_p and C_pk as the goal for a validated process.

 

Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the Operational Qualification (OQ) phase of process validation.

 

Risk Management, as defined in ISO 14971, requires the inclusion of production processes. Processes that require validation have the greatest risk, since they are not fully verified. In addition, they often involve the production process with the greatest risk, such as sterilization.

 

The presentation looks at these aspects of process validation using the unifying approach of a statistical model. Rather than a fundamental examination of how to perform process validation, this seminar covers the tools necessary to use the statistical model.

GHTF recently posted this proposed guidance document at www.ghtf.org. The document, a member of the series on auditing, covers audits of a device manufacturer’s system to control suppliers.

 

The Global Harmonization Task Force (GHTF) is an international organization that encourages regulatory practice convergence to ensure the safety, effectiveness / performance, and quality of medical devices; promoting technological innovation; and facilitating international trade. GHTF publishes and disseminates harmonized documents on basic regulatory practices.

 

Study Group 4 (SG4) covers work in the area of Quality Auditing. This new draft (Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of manufacturer control of suppliers) joins a series of auditing guidance documents already issued:

 

SG4/N28R4:2008 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements

 

GHTF-SG4-(00)3 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements – Supplement 2: Training Requirements for Auditors

 

SG4/N30R20:2006 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy

 

SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports

 

The proposed guidance also refers to:

 

SG1/N055:2009: Definitions of the Terms Manufacturer, Authorized Representative, Distributor, and Importer

 

SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

When a medical device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.

Ombu recently taught a Certified Biomedical Auditor (CBA) course for Granite State ASQ. To help develop the course material, we did a comparative analysis of the CBA Body of Knowledge (BoK) with the Certified Quality Auditor BoK.

The Medical Device Classification slide presentation explains the classification system in the US, the EU, following the Medial Device Directive (MDD), the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk-based approach implemented by regulatory authorities.

The Global Harmonization Task Force (GHTF) has announced the availability of a proposed guidance document on CAPA systems. Proposed by Study Group 3 – Quality Systems it is entitled Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes. The draft is currently open for comment. You can obtain a copy of the document and the comment forms at www.ghtf.org.

A presentation on Supplier Quality Agreements based on ISO 9001 is now in the Ombu Library in the “Managing the Supply Chain” section. The presentation, prepared by Dan O’Leary, was the workshop topic at the Jan. 20 NAPM-NH meeting. The presentation is accompanied by a template that user can employ as the basis for a Quality Agreement.

A presentation on Quality Agreements for medical device manufacturers is now in the Ombu Library. The presentation, prepared by Dan O’Leary, was made to an FDA News virtual conference and to the Worcester MA section of the American Society for Quality. The presentation is accompanied by a template that user can employ as the basis for a Quality Agreement.

The presentation on Outsourcing and ISO 9001 is a description of the Outsourcing changes moving from Clause 4.1 to Purchasing (Clause 7.4) to Measuring and Monitoring (Clause 8.2). The addition also includes a reformatted version of the ISO guidance document.

ISO issued ISO 9004:2009 Managing for the sustained success of an organization – A quality management approach. According to the ISO website, it is available as of October 30, 2009. The description from ISO says, “ISO 9004:2009 provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity.

 

ISO 9004:2009 is not intended for certification, regulatory or contractual use.”

 

 

This presentation describes the methods involved handing complaints. It presents two cases that might arise in dealing with servicing and follows them through the interlinked processes required by the FDA. This includes Complaints, CAPA, Medical Device Reporting, Corrections & Removals, Design Changes, and Risk Management.

 

The information distinguishes between records the manufacturer is required to maintain and reports that must be submitted to the FDA. Reports are characterized by the event that triggers the report, the allowed time to report, and the report’s contents. Records are characterized by the event that creates the record and the record’s contents.

The FDA published an updated list of consensus standards on Tuesday September 8, 2009. You may view it at http://edocket.access.gpo.gov/2009/pdf/E9-21609.pdf

 

The summary of the announcement says, “The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 022’’ (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”

This paper, prepared for Ombu customers, describes two aspects of selecting an AQL for attribute sampling plans.

 

The AQL is the “worst case” process average you, as the customer, are willing to accept from your supplier. The supplier could be either internal or external.

 

The AQL is also a point on the Operating Characteristic (OC) curve. The OC defines the long term probability of accepting lots from various process averages. Traditionally, the AQL is the point with a process average that has a 95% probability of acceptance.

The New England Discussion Group (NEDG) of ASQs Biomedical Division will hold a one day workshop entitled “Complaints and Beyond” on Thursday, Oct. 15, 2009 at the Conference Center at Waltham Woods. Dan O’Leary is one of speakers, discussion the relation between Servicing, Complaint Management, and FDA reporting (including MDRs, Corrections, and Removals).

The FDA has proposed new rules requiring electronic MDR submissions for device manufacturers. The proposed rules, published in the August 21 Federal Register, are open for comment until November 19, 2009.

 

The proposed rules amend 21 CFR Part 803. In addition, the FDA has developed a draft guidance document that describes how to submit electronic MDRs in the new program called eMDR.

 

Low-volume reporters (few or infrequent reports) can use the CDRH eSubmitter (CeSub) software, to submit one report at a time. With CeSub, you manually enter all the pertinent MDR report information into the CeSub program. The program produces the message needed to transmit the report to FDA. The CeSub program also permits you to print a copy of the submitted report. The CeSub software and instructions for installation are free.

 

High-volume reporters (numerous or frequent reports) can develop an application using the prescribed FDA format to create an electronic MDR submission directly from adverse event information in the reporter’s computer system. The file may contain multiple reports in a single submission.

 

The proposed rules do not change the required timeline for reporting. Events must be submitted within 30 calendar days of the manufacturer’s becoming aware of the event. Events which require remedial action must be filed within 5 working days.

 

The proposed rules may be found at www.regulations.gov under Docket Number FDA–2008–N–0393.

 

The draft guidance document may be found at www.regulations.gov under Docket Number FDA-2008-D-0395.

 

The draft Guidance Document may also be obtained from the FDA at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm

 

 

During a recent speech, the new FDA Commissioner, Dr. Margret Hamburg, announced a plan speed up enforcement activities, i.e., shorten the time from an inspection to a Warning Letter. The plan, scheduled for implementation beginning September 15, 2009, is to issue a Warning Letter for significant violations that may lead to enforcement action without taking into consideration information received after 15 days from the date of the FDA 483 (Report of Inspectional Observations).

 

In the past the FDA has delayed warning letters while it reviews information submitted by the firm. When the firm has made multiple submissions, sometimes over many months, the agency has reviewed them and postponed issuing a Warning Letter as a result. Under the new policy, if the FDA receives a response to the 483 within 15 business days, it will consider the response in the decision to issue a Warning Letter.

 

Information received after 15 business days will be reviewed as part of the response to the Warning letter.

 

You may review the new plan in two places.

• The Ombu Library contains a copy of the Notice from FDA
• You can review the official version at www.regulations.gov by entering Docket Number FDA-2009-N-0335.

 

You may read Dr. Hamburg’s remarks: Effective Enforcement and Benefits to Public Health, presented to the Food and Drug Law Institute on August 6, 2009 at

http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm

This paper, prepared for Ombu customers, describes some very valuable, but little know resources that can help you implement ISO 9001. It describes documents in the following areas:

• Definitions of terms
• Guidance documents on specific portions of ISO 9001
• Official interpretations of the standards
• Guidance documents on auditing Quality Management Systems

 

The paper describes each of these and provides links to the websites. All the referenced documents, except ISO 9000:2005, can be downloaded at no charge.

ISO recently issued corrigenda for these two standards. You can download each of them from the Ombu Library at no charge.

 

For ISO 9001, the changes are:

Table A.1, the Correspondence between ISO 9001:2008 and ISO 14001:2004 is replaced

Table B.1, the Changes between ISO 9001:2000 and ISO 9001:2008, some rows are replaced

 

For ISO 13485 the changes are:

“ISO 9001” is replaced by “ISO 9001:2000” throughout the document

In the bibliography, “ISO 13641” is replaced by “EN 13641”

 

Since both ISO 9001 and ISO 13485 are documents of external origin, a good quality system will have the corrigenda available.

 

 

Dan was invited by FDA News, the conference sponsor, to join an expert panel discussion about the vexing problems of medical device supplier quality. The conference, scheduled for August 20 and 21 in Arlington, VA is “Assuring the Integrity of Drug and Device Raw Materials and Supply Chains”

 

Among the other speakers are Distinguished FDA Faculty:

• Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA
• Rick Friedman, Director, Division of Manufacturing & Product Quality, CDER, FDA

Ombu has published the new schedule for Medical Device Manufacturing Seminars. This family of seminars includes Process Validation, Risk analysis (ISO 14971), and CAPA Systems. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Ombu has published the new schedule for Management System Methods Seminars. This family of seminars includes Internal Management Audits and Effective Management Review. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Dan O’Leary presented a talk at BosCon 2009 on CAPA systems. The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with Preventive Action, Correction, and Corrective Action. Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency. We also explore the relationship that CAPA system has to other systems in the regulations including corrections and removals and management review.

The Worcester Section of ASQ scheduled a workshop on Acceptance Sampling Dan O’Leary conducted the workshop; his slides are now available in the Library section of OmbuEnterprises.com.

ASQ has announced a revision of Certified Reliability Engineer Body of Knowledge (CRE – BoK). The revised BoK is scheduled for its first use on the October 2009 exam. The Quality Council of Indiana (QCI), publisher of the CRE Primer, will update this well known and valuable reference book. Dan O’Leary was invited to join the team developing the new material for publication.

Quality Management Systems, such as ISO 9001, ISO 13485, and FDA QSR, require scheduled audits. As the economy cools, companies have trouble maintaining the internal audit schedule because fewer resources are available. Outsourcing the process, or at lest part of it, is a major opportunity for cost saving. Using an outside firm, such as Ombu, provides more effective audits at lower overall cost. Your employees focus on the activities that produce revenue, while skilled auditors help identify problems that could cost you money in the future.

 

Please contact us at 603-209-0600 or Dan@OmbuEnterprises.com to discuss your internal audit program and learn how we can help.

We added a new paper describing how to develop and implement process metrics based on the process criteria for efficiency and effectiveness.

 

Title: Attributes Acceptance Sampling – Understanding How it Works

 

Abstract: Attribute sampling is a powerful tool in the Quality Engineer’s toolkit. This presentation makes clear how these sampling plans work. We explain how the Operating Characteristic (OC) curve describes lot acceptance and define the key points on the curve. We show how to calculate the curve, illustrating simple methods using Excel. With this background, we examine two popular sampling plans: ANSI/ASQC Z1.4 and c=0. Z1.4 contains single, double, and multiple sampling plans. We show the tradeoff between these plans in terms of risk and cost. The standard also contains switching rules, which can help you reduce inspection costs. We also describe the c=0 plans and compare them with the corresponding Z1.4 plans. These plans have advantages and disadvantages, which are easy to understand by comparing the OC curves.

The NAPM – NH Chapter scheduled a workshop on ISO 9001:2008 to educate purchasing professionals on ISO 9001, included the revisions in the 2008 version of the standard. Dan O’Leary will conduct the workshop. His slides are now available in the Library section of the OmbuEnterprises.com.

Ombu has published the new schedule for Statistical Quality Methods Seminars. This family of seminars includes Acceptance Sampling, Statistical Quality Control, and Fractional Factorial Design of Experiments. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Compliance on Line is one of the world’s major providers of on-line training and webinars. Ombu has joined the faculty to provide training on medical device and quality issues. Look at http://www.complianceonline.com/ to see the broad and exciting offerings they provide.

Ombu has published the new schedule for Medical Device Manufacturing Seminars. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

We look forward to seeing you at a Seminar.

The FDA has extended the comment period on the draft Guidance Document on process validations. The comment period now closes on March 16, 2009. The guidance comes from the following FDA Centers: CDER, CBER, and CVM. It does not cover medical devices, and therefore doesn’t replace the current Guideline on General Principles of Process Validation, dated May 1, 1987. You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA-2008-D-0559.

The presentation, entitled “Preventive Action, Correction, and Corrective Action: From Requirements to Effective Processes” The abstract is, “The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with these terms. Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency.”

 

BosCon is scheduled for April 28. You find out more information at http://www.asqboston.org/BOSCON/boscon.htm

 

The FDA’s public workshop, on the proposed Unique Device Identification System is scheduled for February 12, 2009 in Gaithersburg, MD. The purpose of the public workshop is to obtain information to help FDA better understand the issues involved in the establishment of a unique device identification system (UDI system) and request comments on this topic.

 

President Bush signed into law an amendment to the Food, Drug, and Cosmetic Act requiring the establishment of a UDI system. Specifically the new section 519(f) states, “The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.”

 

You can find more information about the UDI system at http://www.fda.gov/cdrh/ocd/udi/

 

The EU’s REACH Directive limits the amount of certain chemicals included in products imported to the EU. Suppliers of articles that contain substances on the Candidate List in a concentration above 0.1% (w/w) must be able to provide certain information upon request.
You may view the candidate list at http://echa.europa.eu/chem_data/candidate_list_table_en.asp

Citing the need to “develop a better regulatory environment, one that is simple, understandable, effective and enforceable”, the EU proposed revisions to the two directives. The proposed RoHS Directive includes medical devices in the scope. The proposed Directive cites products covered by the MDD and by the IVMDD. The list of banned substances is not changed, but four new substances have been identified for priority assessment and possible inclusion on the list of banned substances. You can get more detailed information about the proposals at http://ec.europa.eu/environment/waste/weee/index_en.htm

The FDA issued a draft Guidance Document on process validation for comments and suggestions. The comment period closes Jan. 21, 2009. The guidance comes from the following FDA Centers: CDER, CBER, and CVM. It does not cover medical devices, and therefore doesn’t replace the current Guideline on General Principles of Process Validation, dated May 1, 1987. You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA-2008-D-0559.

The FDA issued a draft Guidance Document on IVD Assay Migration for comments and suggestions. The comment period closes April 6, 2009. The guidance covers “Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed.” However, it may also apply to 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply and to devices where the transition specific concerns. You can view the draft guidance at http://www.fda.gov/cdrh/oivd/guidance/1660.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA–2008–D–0642.