CFR section
21 CFR 56.104(c): Exemptions from IRB requirement
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 56.104(c) |
|---|---|
| Section | Exemptions from IRB requirement |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (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. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.