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 Learning Program for premarket reviewers, is scheduled to begin as a pilot program in 2012.
This program will include visits to academic institutions, manufacturers, research organizations, and health care facilities and is intended to give reviewers a better understanding of how medical devices are designed, manufactured and used. The agency hopes the program will help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.
Shuren said:
Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices.
Enhancing staff training is one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process.