Medtronic, BSX and Other Device Giants Speak Out on IOM’s 510(k) Report

With the release of its 510(k) report, the IOM (Institute of Medicine) and FDA (U.S. Food and Drug Administration) clearly are at odds about the efficacy of its much-criticized device approval process. But in the few days since the report was released, the FDA has found an unlikely ally in the companies that have long criticized the agency’s product endorsement procedures.

On July 29, the IOM concluded its evaluation of the controversial 510(k) process with a rather shocking announcement: The entire process should be scrapped and a new framework should be developed. This week, device companies began to offer their take on the report.

“Let’s have that discussion,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, at an Aug. 2 town hall meeting in St. Paul, Minn. (which was planned before the IOM scheduled the release of its report). “If there are any recommendations that make sense, we’ll consider them.”

A statement from Minneapolis, Minn.-headquartered Medtronic Inc. showed its support. “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,” the statement read.

Natick, Mass.-based Boston Scientific Corp., which employs about 5,000 people in Minnesota, noted the IOM report states that the committee “does not believe that there is a public health crisis related to unsafe or ineffective medical devices” and also issued a statement in support of the FDA.

“Boston Scientific’s first priority continues to be patient safety,” the statement read. “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 the approach during the past 35 years.”

Both companies conveyed their concern with the role that pure science plays in the process. Boston Scientific lauded the FDA, saying the agency “routinely requires the submission of extensive testing results and scientific data,” while Medtronic cautioned that any changes to the current process should be based on “sound science and thoughtful and transparent discussion.”

That issue of transparency has been a hot one in this ongoing debate.

Randy Nelson, president of St. Paul-based Evergreen Medical Technologies, spoke out about this at the town hall meeting. Nelson said that many small device companies are hesitant to speak to the FDA “because you never get the same answer.”

Though industry analysts believe the FDA will not act on the IOM’s recommendations, they are confident the agency will nevertheless attempt to improve the device approval process and address companies’ concerns.

“I don’t think we should eliminate [the 510(k)] process in its entirety,” Shuren said. “It does need some fine-tuning.” He then acknowledged that those tune-ups should come in the form of better predictability, transparency and timeliness.

The FDA currently is gathering public comment about the 510(k) process and suggested changes. The process is expected to be complete by October. Neither Medtronic nor Boston Scientific have stated whether or not they will participate in the public docket.