Sign up for the QMED & MD+DI Daily newsletter.
CDRH Churning Out Inspection Guidances
CDRH has been busy getting inspection-related guidance documents ready. Last week it published the latest version of its general guidance document on inspections of medical device manufacturers. Today it published a draft guidance intended to help manufacturers prepare for FDA review of the manufacturing section of their PMAs, which includes an inspection.
June 20, 2006
1 Min Read
A big problem since the advent of MDUFMA has been that all too often, when a PMA review is done quickly, the sponsor isn't ready for inspection. Let's hope this guidance makes that less common. Electronic comments on the draft guidance can be submitted here until September 18.
You May Also Like
Empatica Launch Next-Gen FDA-Cleared Epilepsy WatchMar 1, 2024|2 Min Read
Safeguard Medical Devices: A Complete Approach to Device Lifecycle SecurityApr 4, 2024|13:00 EDT
Boston Sci Nabs FDA Approval for Agent DCBMar 1, 2024|2 Min Read
Masimo Takes Apple's Hail Mary Pass in StrideFeb 29, 2024|3 Min Read