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Compliance In Focus
Posted by John Lehmann on Wed, May 2, 2012

Is the FDA Pointing the Finger at EU’s Device Review?

Well, it’s been the elephant in the room for the industry as of late. News broke in April aboutPointing the Finger a leaked internal report in which the FDA points out “12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale in Europe but not the United States,” reports The Star Tribune article.

Some believe that going overseas is the best way to gain approval because the process can be faster, and the products end up on the market much quicker then in the US. On the other had, An Oxford University teacher, Carl Heneghan, who has studied device recalls, pointed out the flip side is the European are almost like the test pool for these quick approvals. After all, it wasn’t too long ago that the PIP incident swept the globe. This in fact was an incidence of devices that did not gain U.S. approval but were widely available across Europe.

As imagined this report has created much stir. MassDevice covered the story, pointing out that “The FDA requires that medical devices demonstrate safety as well as efficacy before winning approval to sell in the U.S. The EU system generally only requires safety studies.” And, according to the FDA’s report, “lowering standards of approval for devices in order to speed access can jeopardize patient health and impose high but often hidden costs.”

We wanted to open the discussion floor to you. What are your thoughts on approval system in Europe compared to the U.S.? Do you believe that this report proves the dangers of approving investigational products through different regulatory agencies? Let’s start a dialogue below.

Photo Credit: ilovememphis

Topics: EU, Carl Heneghan, FDA


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