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GUIDANCE DOCUMENT

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices Guidance for Industry and Food and Drug Administration Staff July 2016

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

FDA has developed this document to describe relevant information that should be provided in a premarket submission, (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification [510(k)] submissions, investigational device exemption (IDE) applications and de novo requests), to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. Electrically-powered devices include those that are AC (mains) powered devices, battery powered devices, and active implantable devices.

For the purpose of this document, EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference1), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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.