Some health device features are FDA-cleared or authorized for a specific use, such as an ECG app that detects signs of atrial fibrillation. Many others, such as sleep scores, readiness and stress scores, are wellness features with no FDA review. Clearance applies to a specific feature and intended use, not the whole device. You can check a device's status in the FDA's public databases.
Health tech marketing blurs the line between medical and wellness features. The difference matters when you act on a reading.
Three kinds of feature
| Type | Examples | Reviewed by FDA? |
|---|---|---|
| Cleared or authorized medical feature | ECG for atrial fibrillation, some blood pressure monitors | Yes, for a stated intended use |
| Wellness feature | Sleep score, readiness, stress score, activity | No |
| Estimate shown with a disclaimer | Some SpO2 or temperature trends | Often no |
What clearance means
- It covers a specific feature and intended use, not the whole device.
- It comes with limitations, such as age, position or conditions.
- It does not mean the device is right for you; that is a question for your doctor.
How to check
- Find the feature’s name in the device’s support pages.
- Search the FDA 510(k) or De Novo databases for the company.
- Read the intended use and indications.
- For blood pressure monitors, also check independent validation listings.
Using the data well
Trends over time are often more useful than any single reading. Share readings that concern you with your doctor.
See how to choose a validated blood pressure monitor and compare smart rings and smartwatches. Browse apps and platforms.
Common questions
Is FDA-cleared the same as FDA-approved?
No. Most devices are cleared through 510(k) by showing they are substantially equivalent to an existing device, or authorized through De Novo. Approval (PMA) is a stricter pathway for higher-risk devices.
Are wellness features useless?
No. They can be helpful for trends and habits. They are not designed or reviewed to diagnose conditions.
How do I check a device's status?
Search the FDA's 510(k) and De Novo databases by company or device name, and read the intended use statement.
Do cleared features work for everyone?
Cleared features have specific conditions, such as age limits or settings. Read the instructions and limitations.