CFR section
21 CFR 807.20(a): Who must register and submit a device list?
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 807.20(a) |
|---|---|
| Section | Who must register and submit a device list? |
| 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) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the… |
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