One long-running complaint, among the litany of complaints, about the U.S. Food and Drug Administration revolves around reviewers at the Center for Devices and Radiological Health.
Some say when reviewers change, all consistency in the assessment of new innovative medical devices is lost. Some argue that reviewers are not experienced enough and ask the wrong questions. Indeed, one loud critic of the FDA likened CDRH reviewers to Twiddle Dee and Twiddle Dum.
Dr. Jeffrey Shuren, director of CDRH, admitted that at least some of the criticism is legitimate and outlined some changes to how the reviewers will function in the future. Shuren and some CDRH staff members were speaking at a meeting in St. Paul, Minnesota to answer questions from the medical device community. The two-day visit, which ended in an announcement of a collaboration between the FDA and the local device industry, was organized by LifeScience Alley, a Minnesota trade group.
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 also 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. These efforts should help in the certification of 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 is needed to address them, 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.
