FDA Checks Off Action Item With Training Program Launches

The U.S. Food and Drug Administration has announced two new training programs designed to improve the skills of premarket application reviewers at the Center for Devices and Radiological Health (CDRH). Officials believe that better review skills will lead to improved consistency and efficiency.
“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during premarket device reviews,” said Jeffrey Shuren, M.D., CDRH director. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

The Reviewer Certification Program that officially launches this month is designed for new device reviewers. The 18-month program began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, Infection Control and Dental Devices. Reviewers can take online or live courses in medical devices, food and drug law, regulatory mandates, the CDRH review process, device design and the impact of human factors.
CDRH also is developing the Experiential Learning Program for premarket reviewers, which 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 to give reviewers a better understanding of how medical devices are designed, manufactured and used.

“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,” Shuren said.