These regulations implement the FDA's responsibilities for and authority over
# Medical devices that are permanently implanted or life sustaining or life supporting
# Any other device that the agency may designate
The FDA Modernization Act [[FDAMA]] removed the mandatory tracking requiement and limited FDA's discretionairt authority to require tracking only to class II and class III devices that are:
# Reasonably likely to have serious adverse health consequences upon failure of the device
# Intended to be implanted for over one year
# Life sustaining or life supporting and intended for use outside a device user facility
bag
fda_public
created
Sat, 23 Jun 2012 18:44:15 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 18:44:15 GMT
modifier
dirkjan
tags
CFR
FDA
creator
dirkjan