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# Make Changes to Electromagnetic Compatibility Testing: AdvaMed
- URL: https://www.fdaweb.com/make-changes-to-electromagnetic-compatibility-testing-advamed/
- Published: 2021-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:47:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148694

AdvaMed says that changes in testing requirements for electromagnetic compatibility (EMC) of medical devices should be made with advance notice and appropriate phase-in periods. In [comments](https://www.regulations.gov/document?D=FDA-2015-D-3787-0023&ref=fdaweb.com) on an FDA draft guidance, *Electromagnetic Compatibility of Medical Devices*, AdvaMed says recent changes in testing requirements for *in vitro* diagnostic (IVD) instrumentation “were implemented abruptly and without an implementation phase, contrary to usual FDA practices. This change also resulted in putting two international standards traditionally used as the basis for IVD instrumentation testing on the FDA ‘unrecognized standards’ list.”

AdvaMed provides line-by-line specific comments, as does the [Medical Imaging & Technology Alliance](https://www.regulations.gov/document?D=FDA-2015-D-3787-0022&ref=fdaweb.com).