Electromagnetic Compatibility of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Electromagnetic Compatibility (EMC) of Medical Devices." FDA has developed this guidance document to recommend information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), De Novo request, and certain biologics license applications (BLAs) and investigational new drug (IND) applications to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions. This guidance provides specific technical information to address the recommendations originally described in the guidance entitled "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices," which was published July 11, 2016 (2016 EMC guidance).