Recalls, Corrections and Removals (Devices)
Overview
Definitions
Voluntary Recalls - 21 CFR 7
Mandatory Device Recalls - 21 CFR 810
Corrections and Removals - 21 CFR 806
Regulations
Federal Register Notices
Overview
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
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 under21 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).
Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.
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