21 CFR 56.104
Exemptions from IRB requirement
21 CFR 56.104 is the regulation titled “Exemptions from IRB requirement” in 21 CFR Part 56, Institutional Review Boards. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 312.305, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 56.104 (eCFR, as of Sep 1, 2026)
The following categories of clinical investigations are exempt from the requirements of this part for IRB review:
(a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
(b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
(c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
(d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 56.104.
- 21 CFR 312.305Requirements for all expanded access uses1 letter cites both
- 21 CFR 312.310Individual patients, including for emergency use1 letter cites both
- 21 CFR 312.33Annual reports1 letter cites both
- 21 CFR 312.50General responsibilities of sponsors1 letter cites both
- 21 CFR 312.66Assurance of IRB review1 letter cites both
Latest letters citing it
The letter citing 21 CFR 56.104 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.