FDA Considers Revising 510(k), Industry Balks

//FDA Considers Revising 510(k), Industry Balks

FDA Considers Revising 510(k), Industry Balks

FDA logo  2  200June 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Two years ago the Institute of Medicine, in a report, concluded that the approval process is outdated and needs to be abolished.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



By | 2013-06-13T17:58:34+00:00 June 13th, 2013|FDA News|1 Comment

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

One Comment

  1. msm June 13, 2014 at 7:51 pm - Reply

    How do they get away with it? I know…. $$$$$$$$$

    I had a stimulator implanted in 2006 when the FDA “cleared” it before the testing was concluded. Insurance covered it. Several months later, they did an about face. Rumor had it that the person in charge had his hands in the pockets of the stimulator manufacturer. The device was still “cleared” but was not found to be efficacious because it only helped 10% of the patients. Insurance pulled its coverage. Now, when the battery dies, insurance won’t cover a replacement. I’ll not only lose the benefits it has provided for years, but I’ll have a dead device and battery in my chest.

    All because of the FDA’s relationship with device and drug manufacturers who fund groups like AdvaMed.

    You would think will all of the publicity about mesh, knees, etc, the FDA would be less inclined to accept outside “help” from a group relying on info from one of those manufacturers.

    Why should AdvaMed’s opinion be considered? Why can’t a government agency that receives its funding from tax dollars, stand on its own research and reach its own conclusions? FDA also contracts (outsources) with outside companies to test products. Who has their hands in whose pockets there? The web is so massive and layers are so deep and transactions are washed squeaky clean…. Even a congressional investigation wouldn’t get to the bottom of it for years. There would be some hands in other pockets there too.

    Sorry to rant, but it REALLY ticks me off! I’m tired of being hurt and seeing other people hurt as a result of greed and graft.

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