Final answer:
The FDA clearance for a medical device signifies it is 'substantially equivalent' to an existing device, following the 510(k) pathway. FDA approval is required for new or innovative devices, indicating a higher level of scrutiny for safety and efficacy. The CDRH oversees these processes.
Step-by-step explanation:
When the FDA clears a medical device, it means that the device is declared substantially equivalent to another device already on the market, without raising new questions of safety and effectiveness, despite having different technological characteristics. This clearance is part of the 510(k) regulatory pathway, enabling devices similar to existing ones to be marketed without the need for extensive testing required for new devices. The cleared device must demonstrate it has the same intended use and similar technological characteristics as the predicate device, which is the device already approved or cleared by the FDA.
On the other hand, an FDA approval indicates that a medical device has been rigorously evaluated and deemed safe and effective for its intended use. Approval is typically required for medical devices that are new or that represent a significant technological advancement over existing treatments. FDA approval implies that the device meets higher standards of safety and efficacy and often includes premarket approval (PMA).
The Center for Devices and Radiological Health (CDRH) is responsible for oversight of the safety and performance of medical devices, including the premarket approval process. The introduction of new medical devices often involves a balance between beneficial innovation and potential risks which must be carefully assessed through the FDA's regulatory framework.