FDAnews
www.fdanews.com/articles/138173-fda-proposes-new-policy-for-some-diagnostic-and-radiology-devices

FDA Proposes New Policy for Some Diagnostic and Radiology Devices

July 7, 2011
The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.
The Sacramento Bee