CFR section
21 CFR 56.108(c): IRB functions and operations
PART 56-INSTITUTIONAL REVIEW BOARDS · Subpart C-IRB Functions and Operations
Key facts
| Citation | 21 CFR 56.108(c) |
|---|---|
| Section | IRB functions and operations |
| Part | PART 56-INSTITUTIONAL REVIEW BOARDS |
| Subpart | Subpart C-IRB Functions and Operations |
| Subchapter | 21 CFR A General |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (c) Except when an expedited review procedure is used (see § 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. |
At a glance
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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.