Premarket approval
Revision as of 07:19, 25 August 2020 by Dirkjan (talk | contribs) (Created page with "Premarket approval (PMA) is a process by which Class II Medical Devices are approved to enter into interstate commerce. Typically, a PMA r...")
Premarket approval (PMA) is a process by which Class II Medical Devices are approved to enter into interstate commerce. Typically, a PMA requires detailed labelling identifying the intended use of the device, clinical and nonclincial studies documenting safety and effectiveness, and a detailed summary of the medical device's design, development, verification, validation, manufacturing and distribution.
