FDA plans device reviewer training to shore up 510(k) process

FDA medical device reviewers will complete an 18-month certification program and visit manufacturers, research organizations, academic institutions and healthcare facilities as part of two new training programs intended to improve the consistency of reviews and implement a core tenet of FDA’s proposals to improve the 510(k) device clearance process, the agency said Tuesday (Sept. 6).

Starting this month, all new device reviewers will go through the Reviewer Certification Program, which includes online training and instructor-led courses in medical devices, food and drug law, regulatory requirements, the review process, device design and the impact of human factors. They will also gain practical experience in the medical device review process through the program, which was launched as a pilot project in April 2010.

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