The Ombu Library, in the Medical Device Risk Management aisle, has an article on the relationship between the ISO 14971:2007 hazard analysis and the pFMEA for the device production process.

The Ombu Library, in the Employee Competence and Training aisle, has an article on determining training effectiveness in the context employee competence. It includes information from the recently published ISO Handbook on ISO 13485:2016 and ISO 10015:1999 Quality Management – Guidelines for Training.

On September 6, 2017, FDA-CDER & CBER issued a final guidance document entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.

The guidance document defines an interoperable medical device as a device with the ability to exchange and use information through an electronic interface with another medical product or non-medical product.

During the design phase the guidance recommends applying these considerations to the interface:

• Purpose of the electronic interface
• The anticipated users
• Risk management
• Verification and validation
• Labeling considerations
• Use of consensus standards

Pre-market submission should include:

• A device description
• Risk analysis
• Verification and validation
• Labeling

The Federal Register announcement says that FDA recognizes that it would take up to 60 days to put the guidance document in place. Pre-market submissions for interoperable medical devices made after 60 days should include the information covered by the guidance.

FDA plans to hold a webinar on the guidance document on October 26, 2017.

The recently enacted FDARA, Public Law 115-52, (https://www.congress.gov/bill/115th-congress/house-bill/2430#) includes a section to facilitate international harmonization in medical device inspections. The Ombu Library contains a summary of the section in the FDARA aisle.

Ombu is reorganizing the Library. In some cases, such as ISO 9001:2008, the aisle is removed. In other cases, content will move from one aisle to another. In addition case, the Library will have new aisles. The long term plan will create a set of aisles and articles that better reflects current activities.

ISO has published the handbook for ISO 13485:2016. The new document’s title is ISO 13485:2016 – Medical devices – A practical guide.

According to a description on the ISO website, https://www.iso.org/news/ref2220.html, the handbook is mapped to the structure of ISO 13485:2016 and offers step-by-step guidance for medical device organizations to implement and maintain this quality management system. The handbook can also serve as reference for auditors, regulatory agencies, and certification bodies.

The handbook is available for purchase from the ISO webstore in PDF format for CHF 88.

The FDA Reauthorization Act of 2017, FDARA, extends FDA’s authorization to conduct inspections, including device inspections. The Ombu Library, in the FDA Information aisle, has an article that explains the change.

The law changes the authority’s expiration date from October 1, 2017 to October 1, 2022.

On August 10, 2017, FDA-CDRH published the final guidance document Qualification of Medical Device Development Tools.

A Medical Device Development Tool, MDDT, is a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device. An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making such as clinical outcome assessments, assessments of biomarkers, and nonclinical assessment methods or models.

MDDT Qualification is a conclusion, based on FDA review, that within the stated context of use, the MDDT can be relied upon to have a specific interpretation and application in medical product development and regulatory review.

An MDDT that is qualified for a specific context of use may be used by any device sponsor for that use context.

The guidance document describes three types of MDDTs, distinguished primarily by how the tool measures relevant parameters: Clinical Outcome Assessments (COAs), Biomarker Tests (BTs), and Nonclinical Assessment Models (NAMs).

A Clinical Outcome Assessment (COA) can be made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment.

There are four common types of COAs: patient-reported outcome (PRO) measures, clinician reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures.

A Biomarker Test (BT) is a test or instrument used to detect or measure a biomarker.

A Non-clinical Assessment Model (NAM) is a non-clinical test model or method that measures or predicts device function or in vivo device performance.

The FDA Reauthorization Act of 2017, FDARA, changed the process for device inspections. The Ombu Library, in the FDA Information aisle, has an article that explains the change.

FDA should provide advance notice of the inspection, provide the establishment with a reasonable estimate of the timeframe, provide an opportunity for advance communications, and provide communications during the inspection about its status. The status communication “may be recorded by either party with advance notice and mutual consent”

In addition, the change requires new guidance documents to implement the provisions described above.

A device is now considered adulterated, just as a drug, if the manufacturer refuses entry or an inspection.

The June 9, 2017 Federal Register identifies reusable medical devices that require “validated instructions for use” and “validation data requirements” in premarket notifications, i.e., 510(k)s.

The requirement comes from the 21st Century Cures Act, Section 3059 Cleaning Instructions and Validation Data Requirement, which says that FDA shall identify and publish a list of reusable device types for which 510(k) submissions are required to include (A) instructions for use and (B) validation data regarding cleaning, disinfection, and sterilization.

The Federal Register notice cited above contains the list. In addition, FDA-CDRH update the final guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Appendix E, updated on June 9, 2017, contains the list which includes about 40 product codes.