FDA Considers Revising 510(k), Industry Balks

Jane Akre
June 13, 2013
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June 13, 2013~ “External stakeholders.” That is what the FDA calls medical device manufacturers who also have a decisive role in shaping the regulations they fall under.

Thursday, June 13, the FDA met with stakeholders to discuss modifying the 510(k) approval process. (here)

About 90 percent of the 4,000 medical devices approved by the FDA each year go through 510(k) notification process, which is an exchange of paperwork that can take weeks and cost a few thousand dollars.

The FDA has the option to require more rigid oversight which many consumers claim would help ensure patient safety. Industry currently operates under guidelines that were established in 1997 that impose the “least burdensome” standard on industry to bring new products to market.

Industry would like to keep it that way since it currently has a lot of latitude in deciding how a device makes it to market.

Not surprisingly, industry lobby group, AdvaMed, told the FDA that things are okay the way they are and there need not be any more regulation.

The AdvaMed White Paper, here, just released was created with the help of Boston Scientific. While the group admits there have been problems but “we’re just not aware of any systemic problems that would call for completely eliminating this current guidance and starting over,” according Danelle Miller with Roche Diagnostics.

What's the problem? No problem if you consider transvagainal mesh, heart stents and leads and metal hip prosthesis not a problem. All of those products were approved for market under the current 510(k) notification process. Thousands of Americans have been harmed in the process and the majority of them find out, after the fact, that the FDA largely allows the industry to self-regulate.

Two years ago the Institute of Medicine, in a report, concluded that the approval process is outdated and needs to be abolished.

In its white paper, AdvaMed says the FDA did not intend for the manufacturer to submit a premarket notification for every change in design, material, chemical composition, technology or manufacturing and that the manufacturer is the best qualified to determine if the change to a new medical device could significantly affect its safety or effectiveness.

The meeting was held in preparation for a January scheduled informational meeting between FDA and Congress on whether or not industry can continue to take the fast-track to medical device approval (510(k)) or when more oversight should be applied.

Learn More:

Institute of Medicine, July 2011, Medical Devices and the Public's Health: The FDA's 510(k) Clearance Process and the Public Health


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