Mandatory Device Recalls - 21 CFR 810
Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).
If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the FDA may issue a cease distribution and notification order requiring the person named in the order to immediately:
- cease distribution of the device;
- notify health professionals and device user facilities of the order; and
- instruct these professionals and device user facilities to cease use of the device.
The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a recall of the device.