Boston Sci, Medtronic Weigh In on Possible FDA Changes

Following a harsh review of the FDA system under which most medical devices are approved for market, Boston Scientific said that it "believe[s] in the strength of the 510(k) process," and Medtronic said it supports regulatory changes that are "in the best interest of patients, including ensuring that innovative therapies reach the market."

A U.S. Food and Drug Administration (FDA)-commissioned review of the agency's most-often used medical device-approval process found that the process is flawed and a new framework is needed-spurring mixed reactions within Minnesota's medical device industry.

In September 2009, the FDA commissioned the Institute of Medicine (IOM) to review its 510(k) device approval process-a 35-year-old system used to approve the majority of medical devices for market.

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.

But the 510(k) process isn't a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one, concluded the IOM committee that wrote the report. Its recommendation: The FDA should gather the information needed to develop a new regulatory framework to replace it.

“It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,” IOM committee chair David Challoner, emeritus vice president for health affairs at the University of Florida, Gainesville, said in a statement. “The 510(k) process cannot achieve its stated goals-to promote innovation and make safe, effective devices available to patients in a timely manner-because they are fundamentally at odds with the statutes that govern how FDA must implement the process.”

In a statement, Natick, Massachusetts-based Boston Scientific Corporation-which employs about 5,000 in Minnesota-said that it has a different take.

“Boston Scientific's first priority continues to be patient safety. We believe in the strength of the 510(k) process, as evidenced by the thousands of life-saving technologies that have entered the U.S. market via this approach during the past 35 years. The 510(k) process is grounded in science, and the FDA routinely requires the submission of extensive testing results and scientific data.”

The company added that IOM's committee explicitly stated that it “does not believe that there is a public-health crisis related to unsafe or ineffective medical devices.”

Little Canada-based St. Jude Medical, meanwhile, said Monday that the majority of its products are not subject to the 510(k) approval process-and Fridley-based Medtronic said that its team is in the process of reviewing and assessing the report.

“As a company, we are supportive of regulatory changes that will continue to add clarity and consistency to the process and that are in the best interest of patients, including ensuring that innovative therapies can reach the market,” a Medtronic statement read, adding that any changes to the review process should be based on “sound science and a thoughtful and transparent discussion.”

The FDA said Friday that it will open a public docket to begin receiving public comments on the IOM report. Neither Boston Scientific nor Medtronic explicitly stated whether they planned to submit comments, but both companies expressed a commitment to working with the FDA as it considers the IOM recommendations.

“We appreciate the IOM's report on the 510(k) program and agree that the public should continue to feel confident in the medical devices on the market today,” Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.”

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Shuren said.

He added that many of the IOM's findings are being addressed through changes that the FDA is already implementing to improve its 510(k) program. Earlier this year, the FDA released a plan to update the approval process. Many local and national med-tech companies and organizations responded favorably to the 25 actions that the agency announced as part of the process update-but they were concerned about the IOM recommendations, which hadn't yet been released.