chapter  25
14 Pages

FDA Submittal Requirements and Compliance

The FDA has a host of enforcement options that it can invoke against a medical device or a manufacturer that violates an applicable statutory or regulatory requirement. In a worst case scenario, the FDA can ban a device. Additional severe measures include prosecutions, injunctions, and product seizures. During the course of a facility inspection, the FDA has the authority to invoke administrative detention orders against devices that are believed to be adulterated or misbranded. The agency is also empowered to require that the device manufacturer repair, replace, or refund the price of a violative device.