Final answer:
The FDA is responsible for the approval and clearance of medical devices, as well as their postmarket surveillance. The CDRH, under the FDA, reviews and oversees the premarket approval process for these devices. Furthermore, biological products are regulated by the FDA's Center for Biologics Evaluation and Research.
Step-by-step explanation:
The FDA's Role in Medical Device Regulation
The Food and Drug Administration (FDA) is the regulatory body that approves and clears all medical devices, including surgical implants, prosthetic devices, and in vitro diagnostics. When the FDA clears a medical device, it means the device is found to be "substantially equivalent" to a device already legally on the market, allowing it to be marketed and sold. FDA-approved devices are those that are new or significantly different and have been proven to be safe and effective.
The Center for Devices and Radiological Health (CDRH) is a branch of the FDA that specifically oversees the premarket approval process, ensuring that medical devices meet the necessary requirements. The CDRH also handles postmarket surveillance, including the issuing of alerts, notices, and recalls if safety issues arise with devices that are already on the market.
In regards to specific medical devices, even those with unique statuses such as the medical maggots approved for use as a prescription medical device, the FDA plays a crucial role in their regulation. Additionally, the Center for Biologics Evaluation and Research ensures the safety of biological products, including vaccines and blood products.