FDA Human Subject Regulations - 21 CFR 50, 56, 312, and 812

FDA Human Subject Regulations: 21 CFR 50, 56, 312, and 812 explains the rulebook that follows the product rather than the money. This lesson covers INDs, IDEs, significant and nonsignificant risk devices, safety reporting clocks, and every place FDA diverges from the HHS Common Rule. This is Lesson 5 of 26 in IRB and HRPP Administration: From Coordinator to CIP, taught by Angel Reyes, MPH, MCHES, PMP, a public health doctoral candidate and research methodologist. Every lesson is built on PRIM&R's public 2025 CIP Body of Knowledge and Exam References and cites the regulation it teaches, so you can verify it yourself. 5 Key Facts from This Lesson: 1. FDA jurisdiction depends on the product and the intended submission, never on the funding source, so a privately funded drug study can still fall under 21 CFR 50 and 56. 2. FDA regulates clinical investigations, while HHS defines research, and the two terms are not interchangeable. 3. The 45 CFR 46.104 exemptions do not apply to FDA-regulated studies; FDA's exemptions from IRB review are found only at 21 CFR 56.104. 4. Nonsignificant risk device studies still require IRB approval, because that approval stands in for FDA approval of the investigational device exemption. 5. Sponsors send IND safety reports to FDA within 7 or 15 calendar days, and FDA requires continuing review at least annually with no exceptions. Visit https://www.subthesis.com for the full course, more free research and public health courses, and practical research tools. Disclaimer: This video is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.