On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC information that should be provided in a premarket submission for electrically-powered medical devices. While the guidance is in draft and therefore not yet in effect, the FDA clarifies that the document reflects its existing approach on this topic.
When evaluating the EMC performance of electrically-powered medical devices, FDA has recommended that companies utilize either the International Electrotechnical Commission (IEC) 60601-1-2 standard or the equivalent United States (US) version published by Association for the Advancement of Medical Instrumentation (AAMI), both of which are listed in the agency’s consensus standards recognition database. Although these standards include a comprehensive EMC evaluation of the device, the draft Guidance provides further recommendations on the key information that the agency expects during its review of a premarket submission. These include the following:
- Summary of testing identifying the specific functions of the device that were tested
- Testing specifications including device specific pass/fail criteria
- Justification for allowances and deviations to standard
- Device labeling in compliance to standard
- Description of modifications required to pass EMC testing
The items above should be directly addressed in the electrical safety and EMC testing section of the premarket submission along with references to specific locations in the standards test report. The draft guidance also recommends companies reference any device-specific consensus standards in the IEC 60601-1 family which may augment or supersede the requirements in the 60601-1-2 standard.
The agency currently recognizes both the Third Edition of the 60601-1-2 standard published in 2007 and the latest Fourth Edition published in 2014. FDA is currently accepting both standards to allow the industry to transition from the Third to the Fourth Edition, which places greater emphasis on risk management. However, FDA will not accept conformance to the Third Edition after April 1, 2017, meaning that premarket submissions filed with FDA after this date will require conformance to the Fourth Edition. If possible, companies should consider utilizing the Fourth Edition for any new testing to be conducted if there is the potential that a submission will be filed after this date.