Recalls | 合法醫療器材資訊網

Medicaldevicerecallsareusuallyconductedvoluntarilybythemanufacturerunder21CFR7.Inrareinstances,wherethemanufacturerorimporterfailsto ...

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[1] 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.[2] 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[3], Medical Device Recall Authority. 21 CFR 810[4] describes the procedures the FDA will follow in e...