UPenn study finds FDA regulates devices optimally, European regulators are 'too lax'


The FDA is putting increased focus on approving devices faster as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not: "What we found is that the U.S. FDA regulatory process for the devices we looked at, which were second-generation cardiac stents, was pretty close to optimal. And the EU, which has very lax regulatory standards, was actually too lax. If [the EU] were to implement more rigorous informational requirements for getting devices through to the market, they would improve consumer welfare. That surprised us--that the U.S. was so close to optimal, given the calls for reforms at the FDA. We kind of expected the FDA to be too difficult to get through," they wrote. The findings may be less surprising on the other side of the Atlantic. The European Union is trying to reform the continent's regulatory system. It has some questionable practices. For example, the "notified bodies" that test devices for European marketing approval are paid by the medical device manufacturers to perform the service. More

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