The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just 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, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” to comparable products that have previously been cleared by the FDA.
The 510(k) process has come under fire in recent months after major medical device recalls, including the DePuy Orthopaedics ASR hip replacement system, which has affected an estimated 93,000 people worldwide. Critics of the accelerated approval process say it allows devices to enter the market without thorough testing and puts patients at risk for serious injuries.
The Reviewer Certification Program, which began as a pilot in April 2010 with one division of CDRH, will launch this month 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 health care.
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. The program will include visits to academic institutions, manufacturers, research organizations, and health care facilities and is intended to give reviewers a better understanding of medical devices development and the impact of medical devices on patient care.
Source: FDA Plan of Action