CDRH Mulls Alternative Inspection Methods, Random-Sampling Audits
This article was originally published in The Gray Sheet
Executive Summary
FDA expects to begin auditing randomly selected manufacturers of low risk devices by the first quarter of 2002, FDA staffers suggest following submission of the proposal to the Office of Regulatory Affairs.
You may also be interested in...
CDRH Eyes Hospital Reuse After Completing Low-Risk Device Inspection Pilot
The Center for Devices & Radiological Health is considering a "special emphasis" project focusing on hospital reuse during fiscal year 2003
CDRH Eyes Hospital Reuse After Completing Low-Risk Device Inspection Pilot
The Center for Devices & Radiological Health is considering a "special emphasis" project focusing on hospital reuse during fiscal year 2003
Outside Management Consultant To Meet With CDRH To Assess Strategic Plan
Center for Devices and Radiological Health topsiders will meet with an outside management consultant during February to perform an assessment of the center's long-term strategic goals