FDA to 510K Approved Device Company: Sorry, We Might Change our Mind…

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

This isn’t your father’s FDA. It isn’t even George W. Bush’s FDA.

No, FDA vintage 2010 is beginning to look more and more like a revitalized, proactive government agency that wants to flex its muscle when it comes to food, drug and device enforcement.

The latest example? Check out this March 22, 2010 piece in the Wall Street Journal (subscription required) where the Journal reports the FDA is, “struggling to determine whether it has authority to re-evaluate a knee device that it had earlier cleared, raising questions about the scope of the agency’s powers and injecting fresh uncertainty into the medical-devices sector.”

This sounds serious for medical device makers, and it reminded me of the Supreme Court reversing a long-held decision and changing the way the law is interpreted.

Am I overreacting? Probably not says my510k.com blogger Brad Ryba. “It’s a concerning precedent,” he told me the day the story hit the fan. “FDA typically does not rescind an approval once it is granted.”

A concerning precedent indeed. As reported in the Wall Street Journal, industry lobbyist Jeffrey Gibbs says, “…if the FDA could withdraw clearances for approved devices, it could create uncertainty for the industry and chaos for doctors who have used the product for patients. That said, the FDA has only limited options on how to deal with devices after they are cleared, he argued. “Congress has laid out reasons the FDA can revoke an approval, and none of them includes, ‘We goofed,'” he said.

Also, “In a November letter to the FDA, the company said it has been severely damaged by the controversy. ReGen says Menaflex has been used in 220 surgeries in the U.S and about 3,000 in Europe, where it has been on the market for several years. “

Ryba’s interpretation? “The FDA may be trying to show it has changed in response to public scrutiny. This new regime has made it clear that there will continue to be more activity around enforcement,” in the form of additional inspections and warning letters in the months and years ahead.

Certainly the FDA has gotten more aggressive when it comes to food regulation.

Is it the medical device industry’s turn?

Showing 4 comments
  • Reply

    There is an update on this story. Read more here: http://bit.ly/baHt78

    “The head of FDA’s medical device division said the agency would make a decision on the device in coming weeks. The agency’s options include leaving it on the market as is, pulling it, or it could call for additional testing.”


    “While panelists agreed they would have liked to see more data on the device, they largely backed it as a safe and effective therapy.

    “It’s the opinion of the panel that the Regen device overall has a favorable safety profile, however the panel has some concerns that the company’s study does not fully fulfill the scientific method,” Kelly said.

    It will be interest to see what happens going forward. The device industry is carefully watching the situation as well.

  • Reply

    Thanks again Michael for keeping us apprised of FDA activity. It’s difficult for the average consumer advocate to watch even the critical agencies. there are just too many of them. I’m glad there’s someone who stays on top of this!

    And i am also happy to say that my former skepticism regarding FDA is melting away. it took them quite a while to get going, and before they did they were doing a nice impersonation of the Bush FDA, but they now seem to be getting very involved in a lot of important issues. FDA has historically been one of the most consumer-sensitive agencies in the federal government. It would be nice if they could get a substantial increase in funding, so that they could do even more.

    In any case, it’s good to see them back.

  • Reply

    Gotta give the FDA some credit here. In addition to its transparency initiative we’ve talk about before, the agency is also trying to remove some of the mystery about how it handles inspections and other inner workings at the FDA. From where I sit, it appears to be a sincere effort and I believe it […]

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