Dr. Shuren of FDA responds to 510(k) Criticisms

In March, MDCI touched on the sentiment of several medical device industry players and members of the federal government that the FDA is taking too long to approve new products. This feeling was drawn into focus in a blog post by Rep. Joe Pitts on The Hill’s Congress Blog that asked the Administration to improve its time-to-market for medical devices in order to preserve America’s ability to maintain an innovation and manufacturing lead in the industry.

The FDA did not let this particular commentary on its current practices slip by without a response of its own. Specifically, Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH), was quick to find fault with several of the assertions that Pitts made in his article. In particular, Dr. Shuren criticized the Representative’s comparison of the American and European regulatory systems, stating that “fundamental differences” made it “difficult” to evaluate them side-by-side. Dr. Shuren also pointed out that the European Union does not require medical devices to demonstrate efficacy, which is a fundamental aspect of FDA approval.

Pitts was not the only target of Dr. Shuren’s response, as he also addressed a number of inflammatory studies and news reports indicating that not only is American medical device innovation no longer keeping pace with the rest of the world, but that the “fast track” 510(k) approval system used for certain devices as a path to market might contain dangerous flaws relating to safety. Shuren mentioned that a significant component of any perceived medical device approval slowdown on the part of the FDA is related to low-quality manufacturer applications, of which more than half are delayed due to the absence of critical information. This could play a part in the two-year difference between approval times in the United States and the European Union.

The FDA response was aired as part of a House hearing related to the overhaul-in-progress that the FDA is undertaking for the current medical device approval system. MDCI will continue to monitor the FDA’s position regarding its interaction with industry and politicians as it tries to balance the need for protecting public safety with the desire to improve the economic situation for medical device manufacturers located in the United States.

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republished and adapted with permission from MDCI

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