Contesting the 510(k)

Whether it's the national debt “debate,” political recalls and elections, or labor-management issues in professional sports, a combative tension fills the air. In the medical device community, the 510(k) pathway to market lower-risk devices is generating plenty of controversy of its own.

In late July for example, the U.S. Food and Drug Administration reported that it will open a public docket to receive public comments on the Institute of Medicine's report on the 510(k) program. “Medical devices in the U.S. have a strong track record of safety and effectiveness,” said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health (CDRH). “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.”

On its Web site, the IOM said it “finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA's finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

Meanwhile, Stephen Ubl, president and CEO of the Advanced Medical Technology Assn. (AdvaMed), had this to say about IOM's report: “The report's conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health.”

At the May 26 Healthcare Packaging Conference & Workshops 2011 event in Princeton, NJ, Michael Drues, Ph.D. and president of Vascular Sciences exclaimed, “The medical device industry is in a great state of flux.“ Drues, who consults regularly with the FDA, and serves as a consultant to medical device, pharmaceutical, and biologic companies, says, “On the surface, many would say that the 510(k) process is changing even as we speak. However, on a much deeper and more important level, here's my concern: the more things change, the more they remain the same.”

Eric F. Greenberg, legal columnist for Packaging World and Healthcare Packaging magazines, has previously written about the topic. His Eric F. Greenberg P.C. law firm specializes in food and drug law, packaging law, and commercial litigation. Asked about the 510(k) situation, he responds, “FDA has already announced a substantial program of revisions and study of ways to improve the efficiency of the 510(k) process while still assuring safety. It might be prudent to allow FDA to implement these improvements before any other steps are taken.”

Still to come from the FDA, according to the agency, are the following steps:

• “draft guidance to strengthen and streamline the 'de novo classification' path to market for novel low and moderate risk devices that are not substantially equivalent to an existing device

• “draft 510(k) paradigm guidance clarifying certain aspects of FDA's 510(k) substantial equivalence review

• “issue a proposed rule on Unique Device Identifiers this fall. The IoM noted that UDI would be a meaningful change to the agency's postmarket capability.” -Jim Butschli, Editor, Healthcare Packaging