The FDA is providing devicemakers with clarity on what to submit to support claims of electromagnetic compatability for premarket submissions, humanitarian device exemptions, premarket notifications and de novo requests.
The agency provides a checklist of what manufacturers should include in their submissions for electrically powered medical devices in final guidance issued July 11. The final guidance is little changed from draft guidance released in November 2015.
The most notable change is the addition of the requirement that manufacturers define the environment for which the medical device is intended to be used.
Devicemakers should also include the following to support EMC claims: