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.
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fda_public
created
Sat, 23 Jun 2012 13:44:05 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 13:44:05 GMT
modifier
dirkjan
creator
dirkjan