FDA has set in motion two new training programs designed to improve the consistency of medical device reviews "by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH)," the agency says.

The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH's Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, launched in September and is intended to include all new device reviewers.

The program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and healthcare. Reviewers in the program will complete online training modules, instructor-led courses, and obtain practical 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.

"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," says CDRH Director Jeffrey Shuren. "This investment will improve the quality of submission review and make the process more consistent and predictable."

CDRH is also developing a pilot Experiential Learning Program for premarket reviewers. The program will include visits to academic institutions, manufacturers, research organizations, and healthcare facilities. The agency says the new program is intended to give reviewers a better understanding of how medical devices are designed, manufactured, and used. The program is also designed to help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.

"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 says.

The Experiential Learning Program is in the design stage and scheduled to begin as a pilot program in 2012.

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. The 510(k) program has been under fire for its long review times and other problems often associated with inadequately trained reviewers.