February 2021

U.S. Medical Devices Regulatory Update – October to December 2020

NSF’s medical devices regulatory consulting team highlights notable FDA regulatory developments from the fourth quarter of 2020.

Several noteworthy Emergency Use Authorizations (EUAs) were issued for first-of-its-kind COVID-19 diagnostic tests including:

Some key FDA draft and final guidance documents were also issued and are briefly summarized below::

This draft guidance, issued November 17, 2020, describes the information expected in premarket submissions to support a claim of electromagnetic compatibility for relevant medical devices and accessories. The guidance is intended to ensure harmonization with the IEC standards including 60601 and provides additional specificity on how submitters should consider the intended use environment, risk information pertaining to electromagnetic interference, applicable consensus standards, immunity pass/fail criteria, EM interference and labeling. When final, this guidance is intended to replace FDA’s guidance “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”, issued July 11, 2016.

This draft guidance, issued October 15, 2020, describes updated recommendations for certain polymer- and fabric-based devices that contact intact skin, including submission of materials information in lieu of biocompatibility testing in premarket submissions and reliance on quality system requirements and postmarket controls to identify and mitigate biocompatibility-related risks. The FDA has provided contains a specific list of the polymers and fabrics included in the scope of this policy as well as the types of medical devices or materials that are excluded. When final, this guidance will amend or replace applicable sections of FDA’s guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’ ”, issued September 4, 2020.

This final guidance, issued October 15, 2020, describes non-clinical testing considerations for nitinol, which has unique properties and its use as a base material in medical devices is expanding beyond cardiovascular applications.

This final guidance, issued October 28, 2020, extends the deadline for FDA enforcement of PMA requirements for previously 510(k) cleared, necessary AED accessories from February 2021 to February 2022.

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