Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Guidance for Industry and Food and Drug Administration Staff May 2021
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document provides Food and Drug Administration's (FDA's or the Agency'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.
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.