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.
Always verify against the current published text before relying on it for a submission or inspection.
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.
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
21 CFR Part 807: frequently asked questions
Quick answers to common questions about 21 CFR Part 807.
What is 21 CFR Part 807?
21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices — is a regulation issued by the Food and Drug Administration (United States). 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.
Who does 21 CFR Part 807 apply to?
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.
What are the key requirements of 21 CFR Part 807?
FDA 21 CFR Part 807 requires, among other things: 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).
When was 21 CFR Part 807 last updated?
The current version of 21 CFR Part 807 dates from April 2019.