Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, June 6, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Electromagnetic Fields Equipment Design -- standards Equipment Safety -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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), premarket notification (510(k)) submission, investigational device exemption (IDE), De Novo request, and certain biologics license application (BLA) and investigational new drug (IND)1 ) 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 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 guidance provides additional technical information to address the recommendations in the 2016 EMC guidance. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (20 pages))
- NLM Unique ID:
- 9918470188406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918470188406676