FDA in MN: Scrapping 510(k) May Not Be Necessary

Following a harsh review that concluded that a new framework is needed for the FDA's most common medical device approval process, the agency's officials told local industry leaders that the process needs some "fine-tuning" but shouldn't necessarily go by the wayside.

Less than a week after the Institute of Medicine (IOM) recommended that the U.S. Food and Drug Administration (FDA) completely overhaul its most common medical device approval process, agency officials on Tuesday told local executives that a drastic overhaul probably isn't necessary.

According to the Star Tribune, Dr. Jeffrey Shuren, head of the FDA's device division, told industry leaders at a town hall meeting in St. Paul that the agency remains open to ideas to improve the 510(k) device approval process. The FDA is gathering public comments, and the process should be completed by October.

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

In a report released Friday, the IOM said that the 510(k) process isn't a reliable premarket screen of the safety and effectiveness of the devices approved through it and that it cannot be transformed into one. The FDA should gather the information needed to develop a new regulatory framework to replace it, concluded the IOM committee that wrote the report.

The report prompted mixed reactions within the local medical device community. “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,” Natick, Massachusetts-based Boston Scientific-which has significant Minnesota operations-said in an e-mailed statement. “The 510(k) process is grounded in science, and the FDA routinely requires the submission of extensive testing results and scientific data.”

But according to the Star Tribune, Shuren told attendees at the town hall meeting: “I don't think we should eliminate [the 510(k)] process in its entirety. It does have a role; it needs some fine-tuning.”

Shuren and his staff reportedly answered questions for about an hour. Roughly 60 people attended the meeting, which was held at University Enterprise Laboratories. A key theme at the meeting, according to the Star Tribune: The 510(k) approval process needs to become more predictable and transparent. Med-tech companies often complain that it's not either of those things right now.

For example, Evergreen Medical Technologies President Randy Nelson reportedly said at the meeting that small device companies that need FDA approval for their products are reluctant to speak with agency officials “because you never get the same answer.”

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; more than 3,000 devices 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.

To read more in the Star Tribune about Tuesday's town hall meeting, click here.