Full article reprinted from "The Gray Sheet" - May 11, 2009
Find out how FDA's Office of Device Evaluation is restructuring its reviewer training program to put greater emphasis on 510(k) reviews while also creating core competencies across all its review branches.
FDA's Office of Device Evaluation is restructuring its reviewer training program to put greater emphasis on 510(k) reviews while also creating core competencies across all its review branches.
Pre-market reviews within the device center are the focus of growing public attention and government scrutiny, raising questions about the content and rigor of reviewer training in general.
Some device companies and industry lawyers complain that FDA reviewers, particularly those who are new to the agency and unfamiliar with its regulatory mandates, are requesting more information than necessary to allow new products onto the market.
FDA says its demands are often just keeping pace with newer and more complex technologies.
Nevertheless, the agency admits the training program, which includes a mix of classroom and on-the-job experience, needs retooling. ODE says it is adding more specific training materials on 510(k)s, the regulatory pathway by which most devices enter the market.
New reviewers often come to FDA straight out of college with varying levels of scientific expertise, and it can take up to six months to bring them up to speed, the agency concedes.
User-fee funded training, provided by the agency's Staff College workforce development group, is meant to prime them on key scientific and regulatory concepts. That focus hasn't changed, but the course materials are improving, ODE says.
"We have multiple modules on how to review a 510(k) that reviewers created," Barbara Zimmerman, ODE deputy director for pre-market program management, told "The Gray Sheet."
- Jessica Bylander
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