FDA Issues Draft Guidance About Risks of Electromagnetic Interference

January 1, 2016

Manufacturers of electrically powered medical devices should provide information, such as summary testing and specifications, to demonstrate their products don’t pose a risk of electromagnetic interference.

That recommendation comes in draft FDA guidance issued Nov. 2. The document adds that device applications should include the following information to facilitate premarket submissions and reviews:

  • A summary of the testing;
  • The specifications of the standard that were met;
  • The device-specific pass/fail criteria used;
  • The specific functions of the device that were tested;
  • The performance of the device during each test;
  • A justification for any of the standard’s allowances;
  • A justification for any deviations from the specifications of the referenced standard;
  • Evidence of compliance with the reference standard’s labeling specifications; and
  • A detailed description of all changes.

Specific standards mentioned are those in the International Electrotechnical Commission’s 60601-1family and one from the International Organization for Standardization — ISO 14708 for active implantable devices.

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