CDRH Blames Missed Pre-market Review Goals On More Complex Workload

Article preview from "The Gray Sheet"-  May 10,2010

CDRH Director Jeffrey Shuren says a growing workload and an influx of more complex devices caused the center to fall behind on some of its user fee pre-market review performance goals.

CDRH Blames Missed Pre-market Review Goals On More Complex Workload

Article preview from "The Gray Sheet"-  May 10,2010

CDRH Director Jeffrey Shuren says a growing workload and an influx of more complex devices caused the center to fall behind on some of its user fee pre-market review performance goals.

In fiscal year 2008, the agency missed some of its performance goals for PMA and PMA supplement reviews.

The center appears on track to reach its FY 2008 goals for 510(k) reviews, though Shuren acknowledges he has seen some "slippage" in 510(k) review timeframes, as well.

But Shuren says CDRH's workload has gone up across the board, "so you've got to factor that in." The center director estimated that the 510(k) workload is going up by about 12%, while PMA submissions have increased nearly 15% since 2007.

"We're doing the best we can with what we have, but we also have to deal with an increasing workload and increasingly more complex technologies that are coming to us that require maybe more information and a closer look," Shuren said April 22 at the Food and Drug Law Institute annual meeting in Washington, D.C.

Nevertheless, "if the trends are going in the wrong direction, we want to figure out why," he said.

The center is considering developing a pre-market "SWAT team" of reviewers that can be shifted from one product area to another when the center receives a large influx of one particular type of application.

"These people can come in, take off some of the load, so we can try to manage the workload better across the center," the CDRH director said at FDLI.

But Shuren also argued that some performance goals established in the 2007 FDA Amendments Act are very ambitious. For example, FDA committed to reviewing 60% of PMAs within 180 days. Prior to the 2007 reauthorization, FDA committed to reviewing 50% of PMAs in that timeframe.

"We met [the goal] in 2007 because it was 50%," he explained. "Right now, we haven't met it for the 2008 filings, but we've actually beaten where we were in 2007."

He added that FDA was never sure whether it could meet the more aggressive timeline. "What we said is, we're willing to commit and we're going to try," he stressed. "We will ultimately figure out if this is a goal we can meet in time."

- Jessica Bylander

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