Medical devices are regulated by which FDA center, and some devices require Premarket Approval (PMA) to show safety and efficacy?

• A. Center for Drug Evaluation and Research
• B. Center for Biologics Evaluation and Research
• C. Center for Devices and Radiological Health
• D. Center for Veterinary Medicine

Answer: (C)

The main concept is which FDA center oversees medical devices and the Premarket Approval pathway. Medical devices are regulated by the Center for Devices and Radiological Health, which oversees the entire device lifecycle from premarket review to postmarket surveillance. Premarket Approval is the most rigorous FDA review for high-risk devices, requiring substantial evidence of safety and effectiveness before the device can be marketed. This often includes substantial clinical data, manufacturing controls, and labeling plans. Other FDA centers regulate different product areas: drugs are overseen by the Center for Drug Evaluation and Research, biologics by the Center for Biologics Evaluation and Research, and veterinary medicines by the Center for Veterinary Medicine. It’s important to note that not all devices go through PMA; lower-risk devices may be cleared via a different pathway (510(k)) showing substantial equivalence to a legally marketed predicate device, but PMA applies specifically to higher-risk devices where demonstrating safety and efficacy is essential.