FDA Pre-Announced BIMO Inspections Could Reduce Process Delays
This article was originally published in The Gray Sheet
Executive Summary
The bioresearch monitoring (BIMO) reengineering team within FDA's Center for Devices and Radiological Health is considering the use of pre-announced inspections of sponsors of medical device clinical investigations.
You may also be interested in...
BIMO Routine Inspections Will Be Pre-Announced
CDRH's bioresearch monitoring division (BIMO) has started pre-announcing routine audits. Under the new policy, the inspections are being announced about five days beforehand
BIMO Routine Inspections Will Be Pre-Announced
CDRH's bioresearch monitoring division (BIMO) has started pre-announcing routine audits. Under the new policy, the inspections are being announced about five days beforehand
IVDs May Lose IDE Exemption Under BIMO Reengineering Reg Changes
Sponsors of in vitro diagnostic device clinical trials would be required to obtain investigational device exemptions from FDA under a regulation change currently being considered by the agency's bioresearch monitoring (BIMO) reengineering team.