General controls state that a device must not be adulterated or misbranded. In addition, a manufacturer of any medical device must be registered with FDA and maintain a tracking/complaint file and report if any unexpected life threatening injuries or deaths occur from use of the device. Also, the device may not be sold if it has been banned and should include instructions for use. Finally, all devices must be manufactured using Good Manufacturing Practices (GMP).
General Controls
Share / Follow
Recent Blogs
Great New Companion Diagnostics E-Book Released Today
A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011
A torches-and-pitchforks approach to LDT regulations