www.fdanews.com/articles/143100-ghtf-guidance-clarifies-different-fcas-for-devices
GHTF Guidance Clarifies Different FCAs for Devices
January 11, 2012
The Global Harmonization Task Force’s (GHTF) Study Group 2 recommends a three-tiered classification system for field corrective actions (FCAs), according to draft guidance.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor