CDRH to Defer to OCP for Combo Product Review

A change is coming to the review process for combination medical products.

Most medical device firms that produce “combination products”—defined by the U.S. Food and Drug Administration (FDA) as “a combination of two or more of a drug, device or biologic”—prefer to have their merchandise reviewed by the Center for Devices and Radiological Health, or CDRH. But a change in leadership at the FDA is prompting changes to the device review process as well, industry analysts said during the first day of the fourth annual Orthopedic Design & Technology Conference in Fort Wayne, Ind.

“It goes without saying that device companies would prefer to have their products reviewed by the CDRH,” noted Jeffrey Dow, regulatory affairs manager for Synthes Inc., a West Chester, Pa.-based developer, manufacturer and marketer of instruments, implants and biomaterials. “There is a 510(k) review process that they rely on. But recent activity suggests that the CDRH will defer to OCP (Office of Combination Products) review prior to any review of a combination product as a device.”

That “recent activity” turned out to be the fallout over last year’s 510(k) clearance of ReGen Biologics’ Menaflex knee repair implant. Last month, the FDA admitted in a report to “multiple departures from processes, procedures, and practices” in clearing the product for use, claiming the basis for a review was “in question.” The report recommends an independent science-based re-evaluation of the Menaflex 510(k) clearance decision.

As a result of the admission, Dow claims that the Office of Combination Products now will have the final say over whether devices are indeed combination products. “The CDRH may accept an oral opinion, but oral advice is not going to be binding on a company or the FDA,” he said. “Companies are going to be bound by the decision of the OCP.”

While the Menaflex debacle is not solely responsible for the expected jurisdictional change in combination product review, it served as a wakeup call to FDA officials about the integrity of their device approval process. The agency’s report was the latest in a series of high-level critiques of the 510(k) premarket notification process and of the CDRH. That agency has been under fire for its alleged intimidation and coercion of scientists reviewing medical devices.

In an effort to address some of the criticism of the 510(k) process, the Government Accountability Office (GAO) was asked in 2007 to conduct a study of the procedure. The GAO released its report in January; though it did not propose any fundamental changes to the process, it did identify certain weaknesses.

“What’s been going on now with the 510(k) process has been brewing for a while,” said James Ravitz, a partner at the Washington, D.C.-based law firm Arent Fox PLLC. “There’s been a lot of criticism over the years with the 510(k) process but no catalyst for change. The Medaflex incident turned out to be that catalyst event.”