FDA Exempts 1,003 Class II Devices From 510(k) Regs — But Not GMPs

The GMP Letter
A A
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use.

To View This Article:

Login

Subscribe To The GMP Letter