CFR section
21 CFR 812.42: FDA and IRB approval
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart C-Responsibilities of Sponsors
Key facts
| Citation | 21 CFR 812.42 |
|---|---|
| Section | FDA and IRB approval |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart C-Responsibilities of Sponsors |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation. |
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.