The FDA has unveiled two new training programs to enhance the skills of those reviewing premarket applications at CDRH. The training is one of the 25 action items announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process.
The Reviewer Certification Program began in April 2010 as a pilot and will launch this month for all new device reviewers. The program has up to 18 months of training, and courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design and the impact of human factors.
CDRH is also developing a pilot Experiential Learning Program for premarket reviewers. It will include visits to academic institutions, manufacturers, research organizations and healthcare facilities to give reviewers a better understanding of how medical devices are designed, manufactured and used. The program is in the design stage and is scheduled to begin as a pilot program in 2012.
Staffing has been a problem for CDRH for some time now, with inexperienced reviewers often coming on board. "We have high staffing manager turnover, about an 8.6% rate," CDRH Director Jeff Shuren said at a July meeting in Massachusetts. Furthermore, "we have inexperienced reviewers, most with four years of experience or less; our managers, three years or less." He said at the time he's starting a mentoring program and sending people out for training.
- see the FDA release