510(k) reform: Minnesota congressional delegation lines up in opposition of IOM report’s key findings

IOM crushes 510(k)

Lawmakers from the North Star State are falling in line to oppose one of the key findings of the Institute of Medicine’s recent report on the FDA’s 510(k) premarket notification.

Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) issued a joint statement saying that they rejected the IOM’s finding that the FDA should scrap the 510(k) program altogether and start anew.

The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health and released last week, is not binding on the agency but is sure to cause a stir in med-tech circles and draw the attention of members of Congress.

“I believe we need targeted reforms to the 510(k) process to ensure that our companies in the medical device industry can continue to create jobs, develop innovative products, and maintain patient safety,” Kloubechar said in a prepared release. “Scrapping the 510(k) process entirely isn’t what our businesses want and could limit access to life-saving products.”

Kloubechar’s Senatorial counterpart Al Franken added that “calling for the elimination of the 510(k) process could be very harmful to innovation. The report’s recommendations would impose new burdens on the medical device industry, without a clear path to a more effective process. And in the meantime, it would leave Minnesota companies with great uncertainty, and patients without new lifesaving devices.”

Both Franken and Kloubechar have been active voices in the senate supporting the device industry, along with Rep. Erik Paulsen, who heads the Medical Technology Caucus in the House of Representatives. He called the IOM report’s recommendation to scrap the program a “step in the wrong direction.”

“The medical technology industry is already facing unprecedented challenges – a job-stifling innovation tax and an increasingly out-of-touch FDA – and eliminating the 510(k) process would give Europe another leg up in competing for these made-in-America technologies,” Paulsen said. “What the medical devices manufacturers need is consistency in the approval process, not more uncertainty. Instead of replacing 510(k), I intend to work with innovators, physicians, and other stakeholders to streamline the device clearance process at the FDA.”

Sen. Scott Brown (R-Mass.) told MassDevice via email that he was “reviewing the IOM recommendations in the context of MDUFMA reauthorization, with a critical eye on how these recommendations could further add to the uncertainty in the FDA regulatory process for the medical device industry.”

“I will continue to closely follow and monitor these discussions, and listen to the device industry in Massachusetts about the proposed changes to the 510k process,” Brown wrote.

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  1. FDA Regulatory Specialist for Industry says

    I believe the response from the Senators is overly dramatic and misses the value of the IOM Report offers. The 510k/PMA models are antiquated and they need more than a “patch”, they need to be redesigned and based on a risk model and not a predicate model where the predicate can be as much as 35 years old. Continuing this patch work or mosaic approach is not helpful to the patients, physicians, or the medical device industry which includes the FDA. Allowing the current predicate based model to continue prevents innovation and increases the uncertainty for both industry and the FDA reviewers. When a new device is developed, investors want a 510k route regardless of the risk. But if a device does not have a predicate than regardless of the risk, the FDA must view the device in the highest risk until the manufacturer can prove it is not. This is a waste of time and resources both for Industry and the FDA. The FDA has the “de novo” approach but this is a cumbersome, ineffective make shift process that adds no value but creates an enormous amount of work for industry and the FDA. It adds complete uncertainty to regulatory process which investors find unacceptable and will walk away from promising technology because of the regulatory uncertainty.
    The PMA and 510k model approach is antiquated and the EU got it right. Adapt a risk based approach. This is not going to be hard, almost all companies already have EU clearance, they already know how to implement those regulations, and the classification is predictable.
    The majority of complaints regarding FDA reviews are a lack of consistent, predictable, and transparent market applications, regardless if the product is a 510k or PMA. Obtaining classification is only an entry step that has been turned into a road block. The real work that needs to be done regardless of the classification is the training and education of the reviewer. Until we require and fund the FDA to implement a formal Reviewer Training Program that includes a minimum level of expertise, requires continuing education standards, and retention packages, changing the model will not impact consistent, predictable, and transparent reviews of market applications.

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