These regulations implement the FDA's responsibilities for and authority over the establishment, amendment and revocation of performance standards for medical devices. Congress intended performance standards to be a means of establishing generic premarket review of devices by defining requirements for devices that, when met, would reasonably assure safe and effective devices.
bag
fda_public
created
Sat, 23 Jun 2012 18:48:12 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 18:48:12 GMT
modifier
dirkjan
tags
CFR
FDA
creator
dirkjan