Med Device Co’s Respond Favorably to New FDA Regs

Although the 25 actions unveiled Wednesday were greeted with a mostly positive reaction from the medical device industry, the most drastic decisions about the 510(k) device approval process are yet to come.

Medical device companies both locally and nationally had a mostly positive reaction to new guidelines released Wednesday by the U.S. Food and Drug Administration (FDA)-although the agency is still mulling decisions that could have the greatest impact on the industry.

The guidelines were created to update the 510(k) approval process-a 35-year-old system used to approve the majority of medical devices for market. The plan unveiled Wednesday contains 25 actions that the FDA intends to implement this year. The FDA said that it will delay a decision on the most drastic recommendations it's considering-recommendations that would give regulators the power to police device manufacturers.

The world's largest device company-Fridley-based Medtronic, Inc.-said in an e-mailed statement 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.”

“We are in favor of a more predictable and consistent regulatory system, making it possible for more people to get quicker access to the technological innovations companies like Medtronic provide,” the company added. “We would support requirements for additional information for those products where [there's] a higher level of concern about their intended use or their use of a new technology in a new application.” Medtronic said that additional pre- and post-market requirements for devices should be made on a case-by-case basis.

Among the 25 actions that the FDA will implement this year are: /> ¥ streamlining the “de novo” approval process, through which innovative, lower-risk devices are reviewed /> ¥ providing greater clarity about when clinical data should be submitted in support of a 510(k) submission /> ¥ enhancing recruitment, retention, training, and professional development of staff reviewing devices through the 510(k) process /> ¥ making device photographs available in a public database without disclosing proprietary information /> ¥ establishing a new council of senior FDA experts to assure timely and consistent science-based decision making

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

LifeScience Alley, however, said that 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 510(k) approval process.

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. 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.

Last 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.

Late last year, Minnesota legislators on both sides of the political aisle voiced concern about the changes that were initially proposed. They sent a letter to FDA Commissioner Margaret Hamburg, encouraging the agency to consider the impact that a new set of recommendations would have on patient access to devices and Minnesota's economy.