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GUIDANCE DOCUMENT

Magnetic Resonance (MR) Coil - Performance Criteria for Safety and Performance Based Pathway Draft Guidance for Industry and Food and Drug Administration Staff December 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-1650
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway.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and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.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


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1650.

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