New draft guidance released by the US Food and Drug Administration explains what supporting documents some medical device manufacturers should include in premarket applications to prove electromagnetic compatibility (EMC) of their products.

The guidance defines EMC as an electronically powered device to function properly in its intended electromagnetic environment without emitting any electromagnetic disturbances that could interfere with other devices’ proper functioning. Evidence of EMC is typically shown using the International Electrotechnical Commission’s (IEC) 60601-1-2 standard.

In order to prove EMC of their devices under FDA review, premarket applicants should include the following information:

1. Summary of all testing done to support the applicant’s EMC claim
2. Identification of all IEC 60601-1-2 standard specifications met by the device
3. Device-specific pass-fail criteria, as well as how those criteria were chosen
4. List of specific device functions that underwent testing
5. How the device performed during each test
6. Identification as well as justification of any IEC 60601-1-2 allowances used
7. Description and justification for any deviations from the standard referenced for testing; the applicant must show that the deviation did not affect the device’s safety and performance
8. Device labeling and evidence of compliance with the reference standard’s labeling specifications
9. Description of all changes and/or modifications made to the device that were necessary to pass any EMC testing; the applicant must also state that such changes will be included in the final production model of the device

US market applicants should not assume, however, that FDA reviewers will not request additional EMC-related information beyond the data outlined above. Providing the IEC 60601 testing information mentioned in the guidance, however, should address most if not all agency questions regarding a device’s electromagnetic compatibility.

For additional information on US FDA registration requirements for medical device companies, please refer to Emergo's US regulatory process chart and/or video overview of the US marketing authorization process.