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GUIDANCE DOCUMENT

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Draft Guidance for Industry and Food and Drug Administration Staff August 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-2837
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides Food and Drug Administration’s recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.


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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.