Premarket Approval
/ˈpriːˌmɑːrkɪt əˈpruːvəl/
Definitions
- (n.) A regulatory process requiring manufacturers to obtain FDA approval for certain medical devices before marketing to ensure safety and effectiveness.
The company submitted its new pacemaker for premarket approval before selling it in the United States.
Forms
- premarket approval
Related terms
See also
Commentary
Premarket approval is distinct from other FDA clearance routes and typically involves rigorous scientific evidence; drafters should note its legal impact on market access and liability.
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.