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GUIDANCE DOCUMENT

Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment Guidance for Industry and Food and Drug Administration Staff December 2014

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance addresses testing and labeling of passive implants for safety and compatibility in the magnetic resonance (MR) environment. In preparing a premarket approval application (PMA), Investigational Device Exemption (IDE), and premarket notification (510(k)) submission, this guidance document applies to passive implants, i.e., implanted devices that serve their function without the supply of electronic power. Active implants or devices that are not implants do not fall within the scope of this guidance.


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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
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.