Higher user fees may not speed up device regulatory approvals

We may finally have the FDA user fee extension in place for another 5-year round. But the increased funding for device regulation won't necessarily help speed up the regulatory process, according to an interesting item in Forbes by healthcare analyst John Graham. He argues that regulatory approvals slowed steadily after the two previous user fee renewals and their corresponding funding boosts. From 2000 to 2002, the three years before user fees first passed, device companies submitted an average of 4,300 in annual 510(k) submissions and 77 in PMA submissions. But that number dropped during the first user fee cycle (2003 through 2007) to 3,869 and 55, respectively, and then hit 3,979 and 48 from 2007 to 2011, he said. At the same time, FDA staffing expanded and device regulation funding grew steadily. And now it will expand again, doubling to $595 million over the next 5 years. Article

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