How to Verify an FDA Clearance Claim

Registered is not cleared is not approved

FDA uses different verbs for different pathways, and the differences matter. A company that implies FDA review because it is “FDA registered” is, in FDA’s words, misbranding the device.

Sources: FDA, “Are there FDA registered or certified medical devices?”; FDA, Premarket Notification 510(k); FDA, De Novo Classification Request; FDA, Premarket Approval (PMA).

This is not legal or regulatory advice; consult qualified counsel.

How to look up a company or device

1. 510(k): search the 510(k) search by applicant, device name, 510(k) number (K followed by six digits) or product code.
2. De Novo: search the FDA De Novo database by device name or requester.
3. PMA and Devices@FDA: start from FDA, Medical Device Databases (incl. PMA and Devices@FDA). FDA says these are updated weekly.
4. Registration only: the FDA Registration & Listing database confirms registration, which is not authorization.

Then match three things to the marketing claim: the trade name, the company (which may differ from the applicant or requester), and the cleared or authorized indications for use. Search fields can change; if a field is missing, use the database’s own help page.

PCCPs: when an AI device can change without a new submission

A predetermined change control plan describes planned modifications to AI-enabled device software, how they will be developed, validated and implemented, and an impact assessment. FDA reviews the plan as part of the marketing submission. The statutory basis is FD&C Act section 515C, added by FDORA. Changes that follow an authorized PCCP don’t need a new 510(k) or PMA supplement; changes outside it still do (FDA, PCCP for AI-enabled device software functions (final guidance, Dec 2024)).

What it means for startups

• Never market “FDA registered” as if it were clearance.
• Use the precise verb: cleared (510(k)), granted or authorized (De Novo), approved (PMA).
• Keep marketing claims inside the indications in your actual order; investors and customers can check in minutes.

Go deeper

• Is my app a medical device?
• Is It a Medical Device? FDA Checker
• FDA-authorized AI neurology devices (data)
• FDA Breakthrough Devices and CMS TCET

Sources (accessed October 27, 2026)

1. FDA, “Are there FDA registered or certified medical devices?” (page dated Mar 3, 2021)
2. FDA Registration & Listing database
3. FDA, Important reminders about registration and listing
4. FDA, Premarket Notification 510(k)
5. FDA, Premarket Approval (PMA) (page dated May 16, 2019)
6. FDA, De Novo Classification Request
7. 510(k) search
8. FDA De Novo database
9. FDA, Medical Device Databases (incl. PMA and Devices@FDA)
10. FDA, PCCP for AI-enabled device software functions (final guidance, Dec 2024)

Related resources

• SaMD consulting
• Technical due diligence