21 CFR Part 812

21 CFR Part 812 is a section of U.S. federal regulations that governs the use of investigational medical devices in clinical trials. It sets the rules for how these devices can be studied to determine their safety and effectiveness before they are approved for public use. This includes requirements for obtaining approval from the FDA, ensuring informed consent from participants, and maintaining proper records. The goal is to protect participants and ensure that any new medical device is properly evaluated before it reaches the market.