- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document provides the FDA's recommendations on testing to assess the safety and compatibility of medical devices in a magnetic resonance (MR) environment and the recommended format for magnetic resonance imaging safety information in medical device labeling. This guidance applies to all medical devices that might be used in the MR environment. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.
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:
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-2837.