Dirkjan: 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..."

2020-08-25T07:19:46Z

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..."

New page

Premarket approval ([[PMA|PMA]]) is a process by which [[Class II Medical Devices|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.
[[Category:fda]]

Premarket approval - Revision history

Dirkjan: 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..."