December 9, 2019 — The U.S. Food and Drug Administration (FDA) has issued a guidance for industry and FDA administration staff for Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway. The draft is being distributed for comment purposes only.
This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
For the current edition of the FDA-recognized 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.
Center for Devices and Radiological Health
You can download the PDF here.