21 CFR Part 807 – Establishment Registration & Device Listing

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / CDRH • Registration & Listing Compliance

21 CFR Part 807 establishes the requirements for U.S. medical-device manufacturers, importers, contract packagers, and reprocessors to register their establishments and list their devices with the U.S. Food and Drug Administration (FDA). It ensures traceability of regulated devices and provides a public record of all firms legally marketing medical devices in the United States.

“Every device firm must register and list — it’s how FDA knows who you are, what you make, and where to find you when safety matters.”

1) What It Is

Part 807 implements Section 510 of the FD&C Act to create a national registry of medical-device establishments and products. All domestic and foreign firms must register annually and list their devices with FDA before commercial distribution.

Scope & application. Applies to U.S. and foreign medical-device firms, including manufacturers, specification developers, reprocessors, relabellers, importers, and contract sterilizers.

Selected requirements under Part 807:

• 807.20 Registration requirements. All domestic and foreign establishments must register annually with FDA via the Device Registration and Listing Module (DRLM).
• 807.21 Electronic submission. Registrations and listings must be filed electronically through the FDA Unified Registration and Listing System (FURLS).
• 807.22–25 Device listing. Each device must be listed with intended use, product code, classification, and 510(k)/PMA reference if applicable.
• 807.40 Foreign firms. Must designate a U.S. agent responsible for communications and compliance.
• 807.65 Exemptions. Retailers, hospitals, and some custom fabricators may be exempt from registration.

Relation to other rules. Device registration and listing are prerequisites for compliance under Part 820 (QSR), Part 11 (e-records & signatures), and FDA premarket rules (510(k)/PMA).

2) FAQ

Q1. Who must register under Part 807?
All manufacturers, reprocessors, specification developers, importers, and relabelers of medical devices distributed in the U.S.

Q2. What is device listing?
A public record of all devices marketed by a registered establishment, including product codes, intended use, and clearance type (510(k), PMA, or exempt).

Q3. How often must registration be renewed?
Annually, between October 1 and December 31, via FDA’s online system (FURLS/DRLM).

Q4. Do foreign manufacturers need a U.S. agent?
Yes — each foreign firm must designate an authorized U.S. agent to serve as the FDA contact.

Q5. How does Part 807 interact with 510(k) or PMA?
Registration and listing must be completed before marketing a cleared or approved device in the U.S.

Q6. Where can I search registered firms?
FDA’s public database: Registered Establishments & Devices.

3) How It Relates to V5

V5 by SG Systems Global supports device firms under Part 807 by providing controlled recordkeeping, traceability, and integration with postmarket QMS processes.

• Supplier & manufacturer registry. Track registered suppliers, OEM partners, and contract manufacturers with status control in V5 QMS.
• Label & product version control. Link registered device SKUs to versioned labels in eDHR.
• Traceability to listing data. Associate device records with listing numbers and 510(k)/PMA references for inspection readiness.
• Change management. Document design or supplier changes that may impact registration status under Part 820.
• Audit readiness. Centralize all registration, labeling, and compliance records under Part 11 audit-controlled storage.

End-to-end example. A foreign manufacturer registers its facility under FURLS; device SKUs and 510(k) numbers are linked in V5 QMS and eDHR; auditors can instantly trace each product’s regulatory listing and revision history via Part 11-compliant records.

Primary References:
• FDA eCFR: 21 CFR Part 807
• Quality System: Part 820 (QSR)
• Electronic Records: Part 11
• Premarket Submissions: 510(k) / PMA Overview