FDA registration and device listing are not the same as review of a specific product. The FDA describes 510(k) clearance, De Novo classification and PMA approval as distinct premarket pathways, with terms tied to the device and its regulatory route.
FDA device terms describe different records and review pathways. A facility’s registration or device listing does not mean that the FDA cleared, approved or authorized the product.
Status chart
| Term | What the FDA describes | What to look for |
|---|---|---|
| Establishment registration and device listing | A record of a registered facility and listed device; it does not denote approval, clearance or authorization | Facility and device listing details |
| 510(k) clearance | Review of whether a device is substantially equivalent to a legally marketed predicate device | A 510(k) number and matching device record |
| De Novo classification | A pathway for a low- to moderate-risk device with no legally marketed predicate device | A De Novo classification order |
| PMA approval | Premarket approval pathway for high-risk devices | A PMA number and matching approval record |
These pathways are not interchangeable labels. The FDA’s pathway description depends on device classification and the specific submission. Read the record for the exact product and intended use.
Questions to check on a product page
- Does it name a specific FDA pathway or only say the company is registered?
- Is there a clearance, De Novo or PMA identifier?
- Does the FDA record name the same device and manufacturer?
- Does the record’s intended use match the product claim being made?
- Does the wording on the page match the FDA record’s status?
For the database steps, use the FDA record lookup checklist and compare FDA-cleared functions with wellness features. Browse health apps and platforms.
For questions about a device or health readings, speak with your doctor.
Sources
Common questions
Does FDA registration mean a device is approved?
No. The FDA says establishment registration and device listing do not denote approval, clearance or authorization of the establishment or its devices.
Is 510(k) clearance the same as PMA approval?
No. The FDA describes 510(k) as a substantial-equivalence review and PMA as a separate pathway used for high-risk devices.
What is De Novo classification?
It is an FDA pathway for certain low- to moderate-risk devices when there is no legally marketed predicate device.
Which term should a product page use?
Use the status in the FDA record for the exact device and intended use, and avoid treating registration as product review.