CFR section
21 CFR 56.103(a): Circumstances in which IRB review is required
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 56.103(a) |
|---|---|
| Section | Circumstances in which IRB review is required |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR A General |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.