Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Requires device establishments to register annually and list the devices they handle, and contains the premarket notification (510(k)) provisions in Subpart E — including when a 510(k) is required, what it must contain, and the substantial-equivalence determination.
What this does not cover
stated in the document's own scope- It does not set manufacturing requirements; those are in Part 820, which applies whether or not a device needs a 510(k).
- It does not govern class III devices that require premarket approval; those follow Part 814.
- It does not classify devices or create new classifications; Part 860 does, including the De Novo route when no predicate exists.
- A substantial-equivalence determination is not an approval, and section 807.97 makes representing it as one a form of misbranding.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Part 807 does two separate jobs. It requires the owners or operators of device establishments to register with FDA and list the devices they make or handle, and in Subpart E it sets out premarket notification, the 510(k), which is how most class II and some class I devices reach the US market. A 510(k) asks FDA to find the new device substantially equivalent to a legally marketed predicate. Registration and listing apply to establishments whether or not their devices need a 510(k), and a device exempt from premarket notification is still subject to registration, listing and the device quality system rules.
Scope & applicability
Device manufacturers, initial importers and other establishments, plus the 510(k) pathway itself. Registration and listing are the operating permissions; Subpart E is the marketing pathway, which is why this one Part carries both the licence-to-operate and a classification-driven route to market.
Legal basis & how it acquires force
A regulation in Title 21 of the Code of Federal Regulations, issued under sections 510 and 513 of the FD&C Act among others. Registration and listing implement section 510; Subpart E implements the premarket notification in section 510(k) and the substantial-equivalence standard in section 513(i). Registration and listing are submitted electronically. The regulation was last amended on 15 March 2024.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General Provisions | Definitions, including commercial distribution and establishment, and the scope of the Part |
| Subpart B — Procedures for Device Establishments | Who must register and list, initial registration within 30 days, annual registration between 1 October and 31 December, updates, and the information required |
| Subpart C — Procedures for Foreign Device Establishments | Registration and listing by foreign establishments, including the United States agent |
| Subpart D — Exemptions | Categories of persons exempt from registration and listing |
| Subpart E — Premarket Notification Procedures | When a 510(k) is required (807.81), exemptions (807.85), its content (807.87), the 510(k) summary or statement (807.92–807.93), confidentiality, misbranding by reference to a 510(k) (807.97), and FDA’s possible decisions and the substantial-equivalence criteria (807.100) |
Key requirements
- Annual establishment registration and device listing, with electronic submission
- Subpart E — premarket notification: when a 510(k) is required and when a device is exempt
- §807.92 — content of the 510(k) summary, including the substantial-equivalence comparison to a predicate
- Notification of changes that could significantly affect safety or effectiveness, which may require a new 510(k)
Implementation tips
- Exemption from 510(k) is not exemption from registration and listing, nor from the quality system — the three obligations are independent
- The predicate comparison is a regulatory argument, not a specification table: it must show the differences do not raise new questions of safety or effectiveness
International alignment
Part 807 is one of three routes the device regulations provide to market. Part 860 classifies devices and, in Subpart D, provides De Novo classification for a novel device without a predicate; Part 814 provides premarket approval for class III devices. Manufacturing is governed separately by the Quality Management System Regulation in Part 820, and adverse event reporting by Part 803. FDA lists its eSTAR template as mandatory for 510(k) submissions to CDRH and CBER unless exempted.
21 CFR Part 807: frequently asked questions
Quick answers to common questions about 21 CFR Part 807.
When must a 510(k) be submitted?
At least 90 days before a registered establishment introduces a device into commercial distribution for the first time, or reintroduces one that is about to be significantly changed in design, components, method of manufacture or intended use (21 CFR 807.81). A change that could significantly affect safety or effectiveness, or a major change in intended use, requires a new 510(k).
What does FDA look at to decide substantial equivalence?
Whether the device has the same intended use as the predicate and either the same technological characteristics or different ones that, on the data submitted, do not raise different questions of safety and effectiveness and show the device is as safe and effective. The predicate must not have been removed from the market by FDA or found misbranded or adulterated by a court (807.100(b)).
Can a device be marketed while its 510(k) is under review?
No. Section 807.100(a) says that until the applicant receives an order declaring the device substantially equivalent, it may not proceed to market the device.
When is annual registration due?
Each establishment registers annually between 1 October and 31 December, and a new establishment registers within 30 days of starting a covered operation (21 CFR 807.22).