New Training For FDA Reviewers (written by Walter Eisner @ OTW)
The FDA's chief device regulator, Jeff Shuren, M.D., has admitted on more than one occasion that he has a weak bench for reviewing premarket applications for medical devices.
On September 6, he announced two new training programs for review staff at the Center for Devices and Radiological Health (CDRH).
Shuren, the CDRH director, said, “We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews. This investment will improve the qu...
