Final answer:
The FDA requires an Investigational New Drug (IND) application, review of laboratory and animal trial data, and a 30-day review period before allowing human clinical trials. Medical devices must either be FDA cleared or FDA approved based on whether they are substantially equivalent or new, ensuring they're safe and effective for use. Post-approval, some devices may need further studies for safety surveillance.
Step-by-step explanation:
Before a medical device can be tested in human subjects, the Food and Drug Administration (FDA) requires developers to follow a strict regulatory process to ensure safety and efficacy. Initially, comprehensive laboratory data from animal trials must be collected and an Investigational New Drug (IND) application submitted to the FDA's Center for Drug Evaluation and Research (CDER). After a 30-day review period, clinical trials with human subjects may start, unless a clinical hold is imposed due to safety concerns.
For medical devices that are substantially equivalent to those already on the market, a request for FDA clearance is required, demonstrating that the new device is as safe and effective as the predicate devices. For new or substantially different medical devices, they must be FDA approved, showing through data that they are safe and effective for their intended use. During clinical trials, developers must monitor the safety of the device, including any adverse effects, and meet the FDA's rigorous standards before submitting a New Drug Application (NDA) or premarket approval application.
Additionally, the Center for Devices and Radiological Health (CDRH) is specifically responsible for overseeing the approval process for all medical devices. As a post-approval requirement, some devices may also require Phase IV clinical trials or risk management plans for ongoing safety surveillance.