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