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GUIDANCE DOCUMENT

Electromagnetic Compatibility (EMC) of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff November 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-3787


Docket Number:
FDA-2015-D-3787
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Food and Drug Administration (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 electromagnetic compatibility (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 This draft guidance, when final, will replace the FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” (hereafter referred to as the 2016 EMC guidance), published July 11, 2016. This draft guidance is not intended to change current policy, but provides additional technical information to address the recommendations in the 2016 EMC guidance.

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