In a June 2, 2017 letter, FDA extended the compliance dates for Class I and unclassified devices. The compliance date for labels (including date format) and submitting data to GUDID is extended from September 24, 2018 to September 24, 2020. In addition, the compliance dates for direct marking these devices moves from September 24, 2020 to September 24, 2022.

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

The FDA Reauthorization Act of 2017, FDARA, changed the basis for scheduling device inspection. The law has shifted from a calendar basis, once in every two years, to a risk-based schedule. The Ombu Library, in the FDA Information aisle, has an article that explains the change and describes the risk factors.

The recently enacted FDARA, Public Law 115-52, (https://www.congress.gov/bill/115th-congress/house-bill/2430#) includes an amendment that covers medical device accessories. This law repeals and replaces the section on accessories in the 21st Century Cures Act. The Ombu Library contains a summary of the amendments.

In June 2016, the EU published MEDDEV 2.7/1 Rev. 4 Clinical Evaluation: A Guide For Manufacturers And Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. This new version, replacing Rev. 3, includes significant changes. The revision to Rev. 4 does not have an effective data, which has caused significant confusion. Some Notified Bodies expected immediate implementation of the guidance in the manufacturer’s technical file or design dossier. Others expected the manufacturer to develop a transition plan to meet the new requirements in Rev. 4.

TÜV SÜD extended its implementation timeline to allow manufacturers more time to ensure compliance. On May 5, 2017 the EU published the Medical Device Regulation with a transition period to May 25, 2020. During this time, TÜV SÜD intends to accept clinical evaluation to Rev. 3 or Rev. 4. From May 26, 2020, clinical evaluations must implement Rev. 4.

It is not clear if other Notified Bodies will follow this approach.

On June 15, 2016 FDA issued a final rule Use of Symbols in Labeling. The rule is effective from September 13, 2016. The rule allows symbols in medical device labeling without adjacent explanatory text, i.e., “stand-alone symbols” when:

• A national or international standards development organization (SDO) developed the symbol
• A standard authorizes the “standardized symbol” for stand-alone use
• The manufacturer includes a symbols glossary in the labeling for the device

To support the rule, FDA published a new standards-recognition notice to modify the current list of recognized standards.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-13990.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

An FDA webpage provides information https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ucm555598.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

On August 18, 2017 the President signed FDARA into law. The Act may be cited as the FDA Reauthorization Act of 2017.

For device manufacturers, Title II is Fees Relating to Devices. It sets the user fees for the next few years.

In addition, Title VII is entitled Device Inspection and Regulatory Improvements. The title has the following sections.

Sec. 701 Risk-based inspections for devices
Sec. 702 Improvements to inspections process for device establishments
Sec. 703 Reauthorization of inspection program
Sec. 704 Certificates to foreign governments for devices
Sec. 705 Facilitating international harmonization
Sec. 706 Fostering innovation in medical imaging
Sec. 707 Risk-based classification of accessories
Sec. 708 Device pilot projects
Sec. 709 Regulation of over-the-counter hearing aids
Sec. 710 Report on servicing of devices

The IMDRF guidance document IMDRF/AE WG/N43FINAL:2017 Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology structure, and Codes proposes a common system adverse event reporting.

The system uses four distinct sets of terminologies and their associated codes. In general, the codes have a hierarchal structure.

• Medical Device Problem terms/codes
• Cause investigation terms/codes
• Patient problem terms/codes
• Component terms/codes

IMDRF is still developing the system, but when complete it will allow consistent interchange of information between regulators.

The IMDRF website is www.imdrf.org.

Corrections and Removal Reporting

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) has developed an eSubmitter tool which enables program participants to voluntarily complete and submit medical device correction and removal information electronically as outlined by 21 CFR 806. Once packaged, the submission can be sent to CDRH through the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions.

To prepare the report, open eSubmitter and click on “Create New Submission”. The New Submission Data Dialog box will appear. Scroll down to “CDRH: 806 Corrections and Removal Reporting” and highlight the line. Click next at the bottom of the dialog box, and start preparing the report.

In addition, CDRH Learn has a module on electronic submissions of Part 806 reports. Go to https://www.fda.gov/Training/CDRHLearn/default.htm and click on Postmarket Activities. In the Medical Device Recalls section look for the entry “Electronic Submission of 806 Reports of Corrections and Removals”.

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Transition Time Lines, that includes considerations from transition from the MDD and AIMD to the MDR. The article includes both diagrams and bullet points to summarize the plans.

Effective March 30, 2017, FDA is granting an extension for labelers of soft (hydrophilic) contact lenses to comply with the requirements of the Unique Device Identification (UDI) system. The extension states, “Therefore, pursuant to 21 CFR §801.55(d), FDA grants to labelers of the devices listed … an extension of the requirements to provide a unique device identifier (UDI) on the device label and packages, format dates on the device label according to 21 CFR §801.18, and submit data to the GUDID until one year after FDA 1) develops and fully integrates the Technical Solution into the GUDID production system, 2) provides any necessary updated technical specifications to affected labelers, and 3) notifies industry that the extension will expire, through emails to industry, communication via trade associations, and via the UDI website.”

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM550122.pdf