United States (FDA)
21 CFR Part 807: Establishment Registration, Device Listing and Premarket Notification (510(k))
Part 807 is where a device firm first becomes visible to FDA. It covers registering the establishments involved in making or importing devices for the US market, listing the devices they handle, and the 510(k) premarket notification that most class II and some class I devices need before they can be marketed.
At a Glance
- Regulation
- 21 CFR Part 807
- Subject
- Establishment Registration, Device Listing and Premarket Notification (510(k))
- Group
- United States (FDA)
- Industries
- 10 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
Establishment registration and device listing tell FDA who is making, importing or otherwise handling devices for the US market, where, and which devices. Registration and listing are renewed and updated on a recurring basis and are submitted electronically. Foreign establishments must also identify a US agent. Registration and listing do not mean FDA has approved the firm or its devices, and FDA uses the registration data to plan inspections.
The 510(k) section describes when a premarket notification is required and what it must contain. A 510(k) shows that a device is substantially equivalent to a legally marketed predicate device in intended use and technological characteristics, or that differences do not raise different questions of safety and effectiveness. A new 510(k) is also needed when a firm makes certain changes to a cleared device, such as changes that could significantly affect safety or effectiveness or a major change in intended use.
Part 807 connects to the QMS more than it may seem. Deciding whether a design change needs a new 510(k) is a change control activity, and the documentation behind that decision is something investigators can ask to see. Design records also need to support what the 510(k) claimed about the device.
Who It Applies To
- Domestic and foreign establishments that manufacture, repackage, relabel, specification-develop or import devices for the US market, depending on their activities
- Firms planning to market a device that requires premarket notification
- Manufacturers changing a cleared device who need to decide whether a new 510(k) is required
- Contract manufacturers and sterilizers, whose registration obligations depend on what they do
What Auditors Check
Registration and Listing Accuracy
Whether the registered establishment, its activities and its listed devices match what the firm actually does. Discrepancies show up quickly when an investigator arrives.
Change Assessments for Cleared Devices
Documented decisions on whether design, labeling, material or process changes required a new 510(k), with reasoning that holds up.
Design Records That Support the Submission
Whether the design history and verification and validation records support what the 510(k) stated about the device.
Marketed Claims Versus Clearance
Whether labeling and promotional claims stay within the intended use in the cleared 510(k).
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
QMS Build for Startups (Phased)
A QMS built in phases for a device startup: design controls and risk first, the rest before you need it.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
Industry Guides That Reference 21 CFR Part 807
- Class I Device Manufacturers
- Class II Device Manufacturers
- Dental Devices
- Contract Manufacturers and Component Suppliers
- Startups and First-Time Submitters
- Medical Supply Manufacturers
- Distributors and Importers
- Relabelers, Repackagers and Kit Assemblers
- Reprocessors, Refurbishers and Servicers
- Specification Developers
Questions
Does registering our establishment mean FDA has approved us?
No. Registration and listing tell FDA who you are and what you make or import; they do not indicate approval of the firm or its devices. Marketing authorization comes through the applicable premarket pathway, such as a 510(k) or PMA, unless the device is exempt.
When does a change to a cleared device need a new 510(k)?
Part 807 requires a new 510(k) for changes that could significantly affect safety or effectiveness and for major changes in intended use. FDA has published guidance on making that decision. Whatever you conclude, document the assessment as part of change control, because investigators can ask for it.
How does a 510(k) relate to our QMS?
The 510(k) makes claims about the device that your design records must support, and later changes flow through change control and the 510(k) decision. Weak design records can become a problem both for a submission and on inspection. Our submission readiness work reviews that link before you file.
21 CFR Part 807
Check Your Quality System Against 21 CFR Part 807
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