Substantial Equivalence
/ˌsʌbˈstænʃəl ɪˈkwɪvələns/
Definitions
- (n.) The legal standard determining if a new product is sufficiently similar to an existing one to be regulated under the same criteria, often used in food and drug law.
The FDA approved the new medical device based on its substantial equivalence to an existing device.
See also
Commentary
Used primarily in regulatory contexts such as the FDA’s 510(k) process; clarity in defining the predicate product is key to effective application.
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.