FDA Call for Safety Details in Electromagnetic Device Applications

November 25, 2020

Sponsors of medical devices that are electrically powered or have electronic circuitry need to include 11 categories of safety information in their premarket submissions, the FDA said in a draft guidance intended to replace the agency’s 2016 guidance on electromagnetic compatibility of devices.

The guidance applies to filings for premarket approvals, investigational device exemptions, humanitarian device exemptions, biologics licenses, and 510(k) and de novo clearances.

Among other required details, the applications should include a risk assessment and the results of electromagnetic compatibility testing, the agency said.

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