FDA Wants Four-Star Reviews

FDA Wants Four-Star Reviews

Mark Crawford

The FDA is tired of being the rate-determining step when it comes to the medical device approval process. In the field of chemistry, the rate-determining step is the slowest step in a chemical reaction—the reaction cannot go faster than the rate-determining step. To speed up their game, the FDA recently announced its medical device reviewers will undergo more extensive training, starting in September 2011.

The Process

The medical device review process of the FDA’s Center for Devices and Radiological Health (CDRH) has been heavily criticized over the years for being cumbersome and slow. A major factor in these complaints, especially for 510(k) and Premarket Approval Application (PMA) procedures, is high FDA reviewer turnover.

When reviewers change, momentum and consistency are lost. Work is duplicated. New reviewers are often not experienced enough and ask the wrong questions. Sometimes the process has to be restarted from the beginning. This all slows down the approval for new devices, increases costs, and escalates frustration.

According to Dario A. Machleidt on the Frommer Lawrence & Haug “FDA Lawyers Blog,” reviewer turnover at the FDA’s CDRH division is 8.6 percent, or twice the rate of the FDA’s “sister drug and biologic arms.” Jeffrey Shuren, director of the CDRH, indicates that change is necessary to address this issue and that “we need to find the means to handle the ever-increasing workload and reduce staff and manager turnover.”

“Shuren also stated ‘the majority of my reviewers have less than four years of experience and that my front-line managers generally have three years experience or less,’” writes Machleidt.

To make matters worse, adds Machliedt, ratios of managers to reviewers range from 1 to 14 on the high side, to 1 to 27 at the lower end, “which results in a small number of managers, let alone experienced ones, to train and oversee inexperienced reviewers. Further, the negative impact of the CDRH’s high turnover is exacerbated by the fact that innovative medical technologies are becoming increasingly complex and therefore require longer review times even by experienced CDRH personnel.”

In a recent meeting with medical device manufacturers in Minnesota, Shuren announced FDA medical device reviewers will undergo certification and training beginning in September 2011. The goal of this first-of-its-kind program is reducing the frequent turnover of FDA reviewers and streamlining the medical device application process. “Implicit in the FDA’s decision to implement the program is the hope that standardized training will reduce inconsistencies between individual reviewer decisions,” states Machleidt.

If resources and time permit, the FDA also wants its reviewers to get first-hand experience in the field “to see what goes on in the real world” (always a good thing!). As productive as this would be, however, it may be difficult to accomplish with a potential 12.5 percent reduction in the CDRH budget.

Whether all of this happens or not, it is always a step in the right direction when a large government agency like the FDA makes the effort to appease the concerns of the industries it regulates. Ideally the education will include the scientific training needed to handle the new medical innovations, as well as training on technology to better understand the tools being used to adhere to Part 820 for QSR inspections.

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