News | Magnetic Resonance Imaging (MRI) | December 09, 2019

Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway

Guidance for Industry and Food and Drug Administration staff

Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway

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 The draft is being distributed for comment purposes only.

This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway.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Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.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.  

Docket Number:

FDA-2019-D-1650

Issued by:

Center for Devices and Radiological Health

 

You can download the PDF here.

 

Related content:

Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Framework for the Safety and Performance Based Pathway

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