CFR section
21 CFR 807.22(a): Times for establishment registration and device listing
PART 807-ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES · Subpart B-Procedures for Device Establishments
Key facts
| Citation | 21 CFR 807.22(a) |
|---|---|
| Section | Times for establishment registration and device listing |
| Part | PART 807-ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES |
| Subpart | Subpart B-Procedures for Device Establishments |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Food/Cosmetics |
| Regulation text (excerpt) | (a) Initial registration and listing. An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time. |
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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.