Fda Clearance
/ˌɛfˌdiːˈeɪ ˈklɪərəns/
Definitions
- (n.) Official authorization from the U.S. Food and Drug Administration allowing a medical device to be marketed after demonstrating it is substantially equivalent to a legally marketed device.
The company received FDA clearance for its new cardiac monitor, permitting its sale in the United States.
Forms
- fda clearance
Related terms
See also
Commentary
FDA clearance via a 510(k) pathway differs from FDA approval in that it is a less stringent authorization based on equivalence rather than extensive clinical data.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.