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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.