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 quality of submission review and make the process more consistent and predictable.”
Reviewer Certification Program
The first, the Reviewer Certification Program, will launch this month. The program includes up to 18 months of training and requires reviewers to complete online training modules, instructor-led courses, and obtain "critical experience" in the medical device review process. Courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design, and the impact of human factors.
Experiential Learning Program
The second, Experiential Lea...
