CFR section
21 CFR 812.140(b)(4)(v): Records
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart G-Records and Reports
Key facts
| Citation | 21 CFR 812.140(b)(4)(v) |
|---|---|
| Section | Records |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart G-Records and Reports |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (v) A statement of the extent to which the good manufacturing practice regulation in part 820 will be followed in manufacturing the device; and |
At a glance
- 1–9 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.