MN Lawmakers Speak Out on Behalf of Med-Tech Co’s

In a letter sent to FDA Commissioner Margaret Hamburg, eight state legislators voiced concern about the impact that a new set of agency recommendations would have on patient access to devices and Minnesota's economy.

Minnesota congressional delegates on both sides of the political aisle recently voiced concern about proposed changes in the way that most medical devices are cleared for use in patients.

In a letter sent to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, the legislators encouraged the federal agency to consider the impact that a new set of recommendations would have on patient access to devices and Minnesota's economy. The letter was dated November 24 and signed by Democratic Senators Amy Klobuchar and Al Franken; Republican Representatives John Kline, Erik Paulsen, and Michele Bachmann; and Democratic Representatives Betty McCollum, Keith Ellison, and Collin Peterson.

“Prompt access to new treatments and cures should be a key consideration in any proposed changes to the 510(k) [clearance] process,” the letter said. “Changes that may jeopardize that goal should not be made unless there is clear evidence that the changes are necessary to address a demonstrated public health concern.”

The 510(k) clearance process, named for part of a 1976 law, is one of two routes through which a device can gain clearance to be marketed in the United States; the vast majority of devices-more than 3,000 each year-are approved this way. The process allows a therapy to be evaluated based on its similarity to another therapy that's already been approved. In simple terms, 510(k) products are usually slight improvements to technologies that have already been proven safe and effective-and thus, they require a less extensive review and do not need to be officially “approved” in the way that new devices do before they can be marketed.

Earlier this year, the FDA began exploring ways to “strengthen and clarify” the 510(k) process. “Concerns about the program have centered on whether it allows devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development,” the FDA said in an August 4 news release.

“We support the FDA's work to improve the process for the approval of safe and effective Class II medical devices, but we must work to ensure that we continue to foster life-saving innovation and growth,” the legislators wrote in their letter.

The legislators said in the letter that they appreciate the FDA's recent dialogue with Minnesota stakeholders and that a town hall meeting that the agency held in Bloomington earlier this year was a step in the right direction.

“As you know, Minnesota has an active and continually growing medical-device industry,” the letter said, pointing out that Minnesota is home to more than 500 medical-device companies that together employ almost 35,000 Minnesotans whose jobs pay nearly 50 percent more than average statewide earnings.

“Medical technology in America has been one of the few sustained bright spots in our economy over the last five years,” the legislators wrote. “Our state delegation wants to work with you to ensure that the medical-technology industry will continue to play that role for decades to come.”