Lesson 5 · IRB and HRPP Administration: From Coordinator to CIP

5. FDA Human Subject Regulations: 21 CFR 50, 56, 312, and 812 Explained

76 min

After this lesson you can

  • State when FDA regulations apply and how that differs from Common Rule applicability
  • Contrast the FDA definitions of human subject, clinical investigation, and test article with the HHS definitions
  • Describe the IND framework in 21 CFR 312, including exemptions and the roles of sponsor, investigator, and IRB
  • Describe the IDE framework in 21 CFR 812, including significant risk and nonsignificant risk determinations and the IRB's role
  • Locate biologics, radioactive research drugs, and financial disclosure within the FDA scheme

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.

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.

Exam traps

The distinctions exam questions on this topic are most often built to test. Know them cold.

  • FDA applicability depends on the product and intended submission, never on funding

  • FDA defines clinical investigation, not research; HHS defines research

  • The 46.104 exemptions do not apply under FDA; FDA's only exemptions are at 56.104

  • NSR device studies still need IRB approval; that approval is what stands in for FDA approval

  • 7 and 15 calendar days for IND safety reports; 10 working days for UADE reports

  • FDA continuing review is at least annually with no 46.109(f) exceptions

Practice quiz

  1. Question 1
    Under 21 CFR 56.102, a human subject:
  2. Question 2
    For a nonsignificant risk device study, the IDE requirements are considered met when:
  3. Question 3
    A sponsor must submit an IND safety report for an unexpected fatal or life-threatening suspected adverse reaction within:
  4. Question 4
    Which body determines whether a device presents significant risk when the sponsor and the IRB disagree?
  5. Question 5
    Which of the following is an FDA exemption from IRB review under 21 CFR 56.104?

Recap

  • FDA follows the product: clinical investigations of regulated products, regardless of funding
  • Definitions: human subject as recipient of a test article or control; clinical investigation; test article; sponsor; investigator
  • INDs: when required, the 312.2(b) exemption, phases, sponsor and investigator duties, 7 and 15 calendar day safety reports
  • IDEs: exempt, NSR abbreviated, SR full IDE; the 812.3(m) definition; IRB decides, FDA is final; 10 working day UADE reports
  • Biologics, radioactive research drugs, Part 54, Part 11, and the full HHS versus FDA difference table

Coming next

Lesson 6, HUDs, expanded access, and emergency use.

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This course 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.