Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
Submit Comments by 10/01/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
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
- Docket Number:
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Guidance Issuing OfficeCenter 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This draft guidance document provides Food and Drug Administration’s recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance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.