FDA Issues Guidance to Support EMC Claims

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 The final guidance is little changed from draft guidance released in November 2015.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:

• A summary of the testing that was performed to support EMC and the specifications of the standard that were met;
• A summary of the device-specific pass/fail criteria used;
• The specific functions of the device tested and how these functions were monitored;
• Specific information about the performance of the device during each test;
• An identification of and a justification for any of the standard’s allowances that were used;
• A description of and justification for any deviations from the specification of the referenced standard;
• The device labeling and evidence of compliance with the reference standard’s labeling; and
• A detailed description of all changes or modifications that were made to the tested version of the device in order to pass any of the EMC tests. — Tamra Sami