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The 510(k) Program Should Be Saved, Not Scorned


Posted by Brian Buntz on November 16, 2011

FDA is mismanaging what would otherwise be a good regulatory framework.


CDRH’s 510(k) program has received increasingly negative reviews over the past few years, a trend that seemed to culminate with July’s finding by an Institute of Medicine (IOM) committee that it can’t be fixed and should be scrapped. Now, however, comes an authoritative defense of the 510(k) that calls for a completely different approach.

There’s nothing wrong with section 510(k) of the 1976 Medical Device Amendments, says device industry attorney Larry R. Pilot in an analysis written for the Competitive Enterprise Institute, a nonprofit think tank that advocates libertarian principles. Pilot, who helped write the original statute, says the true problem is CDRH’s “poor administration of law and regulations” in processing 510(k) submissions.

Pilot’s 24-page analysis, titled “Stifling Medical Device Innovation: A Response to Critics of the FDA’s 510(k) Clearance Process,” alleges that CDRH’s poor performance has severely hampered the creativity of the domestic medical device industry, compelling many companies to go overseas for their new product development.

Pilot says the 1990 Safe Medical Device Act, which enabled FDA to demand clinical data with 510(k) submissions, transformed the 510(k) process from an “informed notification into a far more rigorous premarket review.” The modern version of the 510(k), which he says is more like a “mini-PMA” process, took an average of 132 days to complete last year, 39% longer than the average from four years earlier.

As a result, “more new devices are now being developed and marketed in other countries where regulatory requirements are more balanced,” he writes. Pilot’s analysis faults the IOM committee for failing to examine CDRH’s deteriorating performance, as he says it had been asked to do by FDA.

Pilot says “the entire [510(k)] process is riddled with confusion, unpredictability, and a lack of transparency.” He argues that Congress should evaluate the center’s management. “Presumably,” he writes, “the [IOM] study was intended to provide exactly that sort of investigation, but it did nothing of the sort.”

Instead, he says, the IOM committee argued that the only way to ensure the safety and effectiveness of medical devices is to subject Class II devices to more comprehensive reviews. “In making this claim, however, the IOM committee ignored the substantial negative effect that the FDA’s existing ‘mini-PMA’ process is already having on medical device innovation,” Pilot writes. He says the committee further ignored conclusions reached by congressional and independent expert committees over the years that the existing regulatory controls are working well.

“Rather than scrapping the entire 510(k) process,” Pilot writes, Congress should more vigorously oversee and investigate FDA’s performance, “and suggest a possible approach that would enable the agency to keep up with developments in this important and highly innovative industry.”

Pilot concludes that the 510(k) notification and PMA approval processes originate from “a good law that has been poorly managed by the FDA.” He writes that “the time is right for Congress to accept the challenge to carefully examine the structure and management of the FDA, and to assure greater accountability.”

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