Franken to FDA: Get Input Before Changing 510(k) Regs

Minnesota Senator Al Franken sent a letter to the FDA, urging the agency to consider input from those in the medical device industry before deciding on changes to the 510(k) device approval process.

Minnesota Senator Al Franken is asking the U.S. Food and Drug Administration (FDA) to consider the medical device industry's suggestions and concerns before making additional changes to the 510(k) device approval process that are now under consideration.

Franken on Tuesday sent a letter to Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, urging the agency to tap the medical device industry's expertise before moving forward with recommendations being considered.

Earlier this year, the FDA released a plan to update the 510(k) approval process-a 35-year-old system used to approve the majority of medical devices for market. That plan contains 25 actions that the agency intends to implement this year. A handful of those actions have already been put into practice, but most of them are scheduled to be implemented later this year.

In addition to the 25 actions that are already being implemented, the FDA has identified seven more controversial recommendations that have not yet been decided on, including clarifying and consolidating some regulatory terms, and clarifying when a device should no longer be available for use as a predicate-a device that is already on the market that can be used to help a similar devices gain FDA approval.

Those recommendations are being reviewed by the Institute of Medicine (IOM), and the FDA expects to receive feedback from the IOM sometime this summer. Click here to see a list of the FDA's planned actions, including the seven recommendations still under review.

In his letter, Franken said that the “wealth of expertise” of the medical device industry is “often neglected when considering changes to the device review process.”

“I strongly encourage you to establish a clear process for soliciting and considering the suggestions and concerns of the medical device industry on any and all recommendations made by the IOM before finalizing or implementing any changes to the process,” Franken wrote.

Franken isn't the first Minnesota representative to speak out about the changes being proposed by the FDA. Late last year, Minnesota legislators on both sides of the political aisle voiced concern about proposed changes to the 510(k) process. They sent a letter to FDA Commissioner Margaret Hamburg, encouraging the regulatory agency to consider the impact that a new set of recommendations would have on patient access to devices and Minnesota's economy.

Many local and national med-tech companies and organizations responded favorably to the 25 actions that the FDA announced in January.

At that time, Medtronic sent Twin Cities Business a statement saying that it commends the FDA for its comprehensive approach to evaluating the 510(k) process, adding that changes “should have a public health benefit and strengthen a system that has a remarkable safety record.”

St. Louis Park-based trade association LifeScience Alley, which has a committee that's been following the FDA's consideration of new guidelines, said in January that it applauds the agency “for operating an open process that has enabled stakeholders to offer real input. . .” The organization said that the 25 actions were “positive changes that reflect many concerns communicated to the FDA over the past several months.”

But the organization also expressed concern with regard to the remaining seven changes that are being evaluated by the IOM, saying it is “concerned about the deferred decisions on seven issues identified as 'problematic'” and worries about a “lack of representation of many key stakeholders” on the FDA committee that's reviewing the approval process.