- Docket Number:
- 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.
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-2020-D-0957.