Pre-Market Approval
/ˌpriːˈmɑːrkɪt əˈpruːvəl/
Definitions
- (n.) A regulatory process by which certain medical devices must receive FDA approval based on safety and effectiveness evidence before marketing in the U.S.
The company obtained pre-market approval for its new implantable device before distributing it nationwide.
Forms
- pre-market approval
- pre-market approvals
Related terms
See also
Commentary
Pre-market approval is a stringent FDA process distinct from 510(k) clearance; drafters should specify which pathway applies when discussing device regulation.
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