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Guidance Issuing OfficeCenter 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.
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:
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.