FDA issues draft guidance on electromagnetic compatibility data in device pre-market submissions

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of safety information in their premarket submissions, the US Food and Drug Administration (FDA) has said in a draft guidance document intended to replace the Agency’s 2016 guidance on electromagnetic compatibility of devices.

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

Among other required details, the applications should include a risk assessment and the results of electromagnetic compatibility testing.
Stakeholders are invited to submit comments by 16 February 2021.