510(k) Process Could Come Under Fire

The Government Accountability Office is preparing a report on whether the 510(k) process is adequate enough to assess the safety and effectiveness of medical devices, and the buzz at the Regulatory Affairs Professionals Society annual conference this week is that it may have some unfavorable conclusions. Some consumer groups and members of Congress have complained that the process is not rigorous enough."Industry and FDA are unified on the 510(k) process.

September 18, 2008

2 Min Read
510(k) Process Could Come Under Fire

We believe it works well, is flexible, and is not undemanding," said Patricia Shrader, senior vice president of corporate regulatory and external affairs for Becton Dickinson, who spoke at a session on the FDA Amendments Act of 2007. "But the GAO report may not be entirely positive. And if the GAO says the bar must be raised, then the impact on IVDs may be rather disproportionate."Similarly strong words were uttered by industry and CDRH personnel during the conference's CDRH executive staff briefing. "The majority of products which have turned out to have severe problems are not 510(k)s," said Susan Alpert, senior vice president and chief quality and regulatory officer at Medtronic. "This program has not created a significant risk for the American public."Pamela Adams, senior vice president and COO at Etex Corp., said the attacks on the 510(k) program arise from misconceptions, particularly that 510(k) products can get on the market without clinical data. In fact, 10-15% of 510(k) applications include clinical data. She said AdvaMed is working to educate policymakers and the media about these misconceptions.CDRH Director Daniel Schultz said the 510(k) program has matured over the years into something that "allows us the flexibility to apply appropriate criteria and thresholds."But, he said, industry should not view the program as an easy way to market, and should not balk if the center asks for more data. "If we want the 510(k) program to survive, and to be based on risk, it has to work both ways," he said. "We will ask for less information about simpler devices, but we will ask more and harder questions as the technology advances. `It's just a 510(k)' is a phrase that should be taken out of our lexicon."-- Erik Swain

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