The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device, as well as the use of appropriate FDA-recognized standards.
EMC as defined by FDA includes immunity to electromagnetic disturbance (interference), and being free of excessive electromagnetic disturbances (emissions) that might interfere with other devices.
In premarket submissions, manufacturers of electrically-powered medical devices typically reference IEC 60601-1-2 (read about the new 4th edition here) or the equivalent U.S. version. In addition, there are device-specific consensus standards, or “particular” standards (e.g., IEC 60601-2-X, where X denotes a particular device standard). These particular standards may augment or supersede the requirements in the IEC 60601-1-2 standard. There are also other consensus standards for electrically-powered medical devices that include information on EMC (e.g., ISO 147083 for active implantable devices).
According to FDA’s guidance, a claim of EMC for a device should be accompanied by this information:
- Summary of the testing that was performed to support EMC
- The specifications of the standard that were met
- The device-specific pass/fail criteria used
- The specific functions of the device that were tested (including essential performance) and how these functions were monitored
- 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 specifications of the referenced standard
- The device labeling and evidence of compliance with the reference standard’s labeling specifications
- A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests.
FDA will accept written or electronic comments and suggestions on this draft through mid-December. Submit electronic comments to http://www.regulations.gov
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Have questions about this guidance, or any other electro-medical device regulatory issue? Ask Pat, our compliance expert. Pat (and MET) have been skillfully performing medical product testing and certification for decades.