Glossary
FDA-cleared
An FDA-cleared device has been reviewed by the FDA and found substantially equivalent to a legally marketed device, typically through the 510(k) pathway. It is not the same as FDA-approved, which is a higher bar used for higher-risk devices.
Why it matters
Device supply codes require a device meeting the FDA definition of a medical device. A consumer fitness tracker generally does not qualify, however good its data looks.
Related
FDA-cleared
Defined here, run in practice.
Device supply codes require a device meeting the FDA definition of a medical device. A consumer fitness tracker generally does not qualify, however good its data looks.
Glossary
FDA-cleared in practice, not just in theory.
We build and run these programmes. If you want to know what this looks like in a real clinic rather than a definition, ask.