CDRH Shifts Sterility Data Controls From Premarket Review To Inspections
This article was originally published in The Gray Sheet
Executive Summary
CDRH will not require manufacturers using "non-traditional" sterilization methods to include validation data in device 510(k)s, but may alert its Office of Compliance of the possible need for an inspection, according to a Nov. 16 "Blue Book" memorandum to Office of Device Evaluation staff