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GUIDANCE DOCUMENT

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Guidance for Industry and Food and Drug Administration Staff October 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2019-D-2837
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit Comments Online

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-2837.

 
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