The Food and Drug Administration (FDA) has developed this guidance document to recommend information that should be provided in a premarket submission (i.e., premarket approval (PMA) application, humanitarian device exemption (HDE), biologics license application (BLA), premarket notification (510(k)) submission, investigational device exemption (IDE) and De Novo request) to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.
Typically, the review of EMC information in a submission is based on the risk associated with malfunction or degradation of the medical device under consideration, where malfunction or degradation could be caused by inadequate EMC.
The review is also based on the use of appropriate consensus standards. This draft guidance, when final, will replace the FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” (hereafter referred to as the 2016 EMC guidance), published July 11, 2016.
This draft guidance is not intended to change current policy, but provides additional technical information to address the recommendations in the 2016 EMC guidance.
To download the guidance document visit https://www.eventura.world/documents