The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices; and by ensuring the safety of our nation's food supply, cosmetics and products that emit radiation.
A recall is a method of removing or correcting products that are in violation of laws administered by the 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. 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). Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to the 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.