Tuesday, November 2, 2021

US FDA draft guidance on EMC of med devices open for public comments for 60 days – Express Healthcare



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Once finalised, this will replace the July 2016 US FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”

The US Food and Drug Administration (US FDA) issued a draft guidance: Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.

The draft guidance outlines information that should be included in pre-market submissions to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions and will be open for public comments for 60 days.

The US FDA has developed this guidance document to recommend information that should be provided in a premarket submission (i.e., premarket approval (PMA) application, humanitarian device exemption (HDE), biologics license application (BLA), premarket notification (510(k)) submission, investigational device exemption (IDE) and De Novo request) to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions.

Typically, the review of EMC information in a submission is based on the risk associated with malfunction or degradation of the medical device under consideration, where malfunction or degradation could be caused by inadequate EMC. The review is also based on the use of appropriate consensus standards.

This draft guidance, when final, will replace the FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”, published July 11, 2016.



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