Medical device industry touts safety of regulatory approval process

The industry group representing medical devices released a new report on Wednesday that touts the safety of a federal approval process the Obama administration wants to overhaul.

Researchers with Battelle examined more than 47,000 devices approved since 1998 through the Food and Drug Administration's 510(k) premarket review process for low- and moderate-risk devices. Battelle scoured FDA recall notices and press releases and found only 77 Class I recalls, which involve  products that could cause serious injury or death, between Jan. 1, 2005, and May 1, 2010 — a .16 percent recall rate.

"What this study shows is that the 510(k) process has an extraordinary safety record," said David Nexon, senior executive vice-president for the Advanced Medical Technology Association (AdvaMed), which funded the study. "If you look at the data, you'll see a situation where it's hard to imagine any other regulatory process that will have as good a record at weeding out unsafe products before they reach patients."

The FDA is currently debating more than 70 changes to the 510(k) process amid concerns that approval rules are too lax, and will be gathering public input through Oct. 4. AdvaMed supports some changes to the program, such as increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale to prevent delays and inconsistencies in the program. But the industry argues that the basic expedited review process is sound and should be preserved to help American products get to market quickly and efficiently.

"Our view," Nexon said on a conference call, "is that this study reinforces a message we've putting out for some time: Reform of the 510(k) program is appropriate, but you need a scalpel, not a meat axe."