Final FDA Guidance Issued on Medical Device Electromagnetic Compatibility
US medical device market regulators have finalized guidance on how manufacturers of electrically powered devices should prove electromagnetic compatibility (EMC) for premarket clearance or approval.
The final guidance covers recommendations first drafted in late 2015 for various supporting documents premarket registrants should include in their US market authorization applications. As Emergo reported when the draft EMC guidance was issued, the FDA recommends several major components in order for a US market registrant to prove its device’s electromagnetic compatibility; these recommendations include:
- Information on the environment in which the device is intended to be used
- Summary of all testing conducted to support EMC claims
- All standard specifications met by the device
- Specific device functions that underwent testing, and how those functions were tested
- Details on any changes made to the device in order for it to pass one or more EMC tests
Affected manufacturers should refer to the full final guidance to familiarize themselves with all FDA EMC recommendations. However, as Emergo noted in its analysis of the initial draft guidance last year, firms should also be aware that FDA reviewers may request additional EMC-related data from applicants beyond the recommended information mentioned above.