FDA director of the Center for Devices & Radiological Health Jeffrey Shuren promised medical device makers at a St. Paul, Minn., gathering that the agency would launch its first reviewer training and certification program, aimed at alleviating long-running concerns about inexperienced application reviewers and frequent application turnover.
Starting in September, the FDA will launch a reviewer certification and training program for the very first time that all reviewers will undergo, Shuren said. He added that, resources and time permitting, reviewers will be sent out in the field to "see what goes on in the real world" beginning in 2012.
Shuren admitted that at least some of the criticism is legitimate and outlined some changes to how the reviewers will function in the future, in efforts to stem industry concerns that inexperienced reviewers and high agency turnover has hampered submissions of innovative medical devices.
But Shuren showed reluctance in using the third-party reviewer program, at least for more administrative functions of the 510(k) review process, as suggested by venture capitalist Pete McNerney of Thomas, McNerney & Partners.
An internal survey showed that there were lots of problems with the third-party review program and that more investment was needed to address issues, Shuren said. He also noted that companies end up paying the FDA more in user fees when they decide to use the third-party review program because often the FDA is correcting problems.
