21 CFR Part 807 — Establishment Registration & Device Listing
21 CFR Part 807 establishes the requirements for medical device establishment registration and device listing. It implements FD&C Act § 510 [21 U.S.C. § 360].
Structure of Part 807
| Subpart | Content |
|---|---|
| Subpart A (§§ 807.1–807.3) | General provisions and definitions |
| Subpart B (§§ 807.20–807.26) | Who must register and list; submission procedures |
| Subpart C (§§ 807.31–807.39) | Device listing requirements |
| Subpart D (§§ 807.40) | Foreign establishment registration requirements |
| Subpart E (§§ 807.87–807.100) | 510(k) premarket notification requirements |
Who must register (§ 807.20)
- Manufacturers of finished devices distributed in commerce in the USA
- Repackagers and relabellers
- Initial importers
- Foreign establishments that manufacture finished devices exported to the USA
- Specification developers (entities that design devices but contract manufacturing)
Registration timing (§ 807.21)
- Initial registration: Before beginning commercial distribution
- Annual renewal: October 1 – December 31 each year
- Updates: Within 30 days of any change in information (ownership, official correspondent, US agent)
Device listing (§§ 807.31–807.39)
Manufacturers must list each device they market in the USA, providing:
- Device name (common/generic and proprietary)
- Product code
- 510(k)/PMA/De Novo number (if applicable)
- Classification
- Intended use
Listings must be updated within 30 days of any change (new product, product discontinued, change in device information).
Foreign establishment registration (§ 807.40)
Foreign manufacturers exporting to the USA must:
- Register annually in FURLS
- Designate a US Agent physically located in the USA who is reachable during US business hours
- List all devices distributed in the USA