CFR section
21 CFR 807.21(a): How to register establishments and list devices
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 807.21(a) |
|---|---|
| Section | How to register establishments and list devices |
| 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 | Devices |
| Regulation text (excerpt) | (a) Owners or operators of establishments that are subject to the registration and listing requirements of this part must provide the following information to us using our electronic device registration and listing system, except as provided in paragraphs (b), (c), and (d) of this section: (1) Initial establishment registration information as required by §§ 807.22(a) and 807.25; (2) Updates to registration information as required by §§ 807.22(b) and 807.25; (3) Initial device listing information… |
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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.