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
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter 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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All written comments should be identified with this document's docket number: FDA-2020-D-0957.