FDA Issues Draft Guidance on Performance Criteria for Magnetic Resonance (MR) Coils

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway.

Read the Guidance Facts about the draft guidance  This draft guidance is intended to provide performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway.  Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) will have the option to use the performance criteria as identified in a final guidance to support substantial equivalence, rather than direct comparison of the performance of the subject device to that of a predicate device. Submit comments on this draft guidance This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-1650.  Submit Comments Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.