Voisin Consulting Life Sciences glossary icon
Glossary

Pre-Market Approval (PMA)

Loading..
Click a letter to view all its definitions

The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists. PMA regulatory requirements and dossier content is of a much greater complexity for product developers in comparison to alternative 510(k) application file (i.e. need for formal clinical study data, etc.)

Other glossary definitions

S

Somatic-Cell Therapy medicinal Products (sCTP)

These contain cells or tissues that have been manipulated to change their biological characteristics or…

View definition
C

Cost-Effectiveness

Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a…

View definition