FDA-cleared
Also called 510(k) clearance, FDA clearance
FDA-cleared means the U.S. Food and Drug Administration has allowed a medical device to be marketed after a 510(k) premarket notification, in which the maker showed the device is "substantially equivalent" to a legally marketed device, called the predicate. Clearance is the usual route for moderate-risk (Class II) devices.
Clearance is not approval. Approval, for the highest-risk (Class III) devices, requires the manufacturer to show with valid scientific evidence that the device itself is reasonably safe and effective. Clearance rests on comparison to an existing device. Many low-risk (Class I) devices need neither. Drugs are never "cleared"; the word applies to devices, including many diagnostic tests and test kits.
Why it matters after 45
Monitoring devices and at-home tests become part of midlife care, from glucose sensors to sample-collection kits, and marketing often blurs cleared, approved and neither. Knowing which term applies tells you what the FDA actually reviewed, and why a lab-developed test carries a separate label.
Where it comes up
Related terms
References
- U.S. Food and Drug Administration. Premarket Notification 510(k). https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
- U.S. Food and Drug Administration. Is It Really "FDA Approved"? https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
Definitions here are educational and are not medical advice. They explain what a term means; the pages linked above cover what it means for you, and a clinician reviews your own results. Editorial & medical review policy · All glossary terms