Getting the Scoop on 510(k)s

InHealth Panel Looks At The Evidence for New Approaches

fda-questionsIn the halls of government agencies throughout Washington, DC, plans are being made to implement reform measures that will reshape the nation’s healthcare policies—and the health of millions of Americans. But for the medical device industry, few reforms could be more important than those now being considered for FDA’s premarket notification (510(k)) product review process.

For device manufacturers doing business in the United States, the 510(k) process has historically provided the primary route to market. But in recent years, the efficiency of the 510(k) process has come under increasing scrutiny from many quarters—including consumer groups, healthcare professionals, and payers, as well as employees of both device companies and FDA. To get to the bottom of such complaints, government and academic researchers have undertaken several major studies of the 510(k) process within the past year.

Investigators representing several of these recent studies will be brought together for the first time in a panel session on Tuesday, January 11, at OneMedForum San Francisco. The session is sponsored by the Institute for Health Technology Studies (InHealth;, a nonprofit foundation that supports research and analysis on the role of medical technology in advancing healthcare and patient quality of life.

Recent studies of the 510(k) process have appeared during an especially contentious period for healthcare policy. Advocates of a more rigorous premarket review process say that current processes may permit unsafe devices to make their way onto the market. Meanwhile, the device industry complains that current review processes are both unpredictable and slow, preventing patients from gaining timely access to innovative and effective products. FDA acknowledges that problems with the current 510(k) process are complicated, but the agency’s efforts to reform the process are straining the relationships between innovators and regulators.

In the InHealth session at OneMedForum, investigators who have conducted recent studies of the 510(k) process will discuss the challenges involved in getting a clear picture of industry and agency practices as a foundation for improving the regulatory pathways of the future. The panelists will consider what elements should be incorporated into such studies, and how to ensure that research findings are deemed credible among all stakeholders.

Panelists will include Ralph F. Hall, JD, distinguished professor and practitioner at the University of Minnesota Law School; John H. Linehan, PhD, professor of biomedical engineering at Northwestern University; William H. Maisel, MD, deputy director for science in FDA’s Center for Devices and Radiological Health; Josh Makower, MD, MBA, president and CEO of ExploraMed; and Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering at Stanford University.

InHealth has recently funded a study led by Drs. Linehan and Pietzsch, “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” which is collecting input from entrepreneurs, physician-inventors, regulators, and others involved in the design and development of regulated medical products. The study website ( includes an electronic survey geared toward individuals and companies that have previously developed a 510(k) product. Results of the survey will give industry and FDA statistically valid information, helping to provide a realistic basis for new policies and proposals.

“The high-level investigators participating in the OneMedForum panel represent the cutting edge of research in this area,” says Steve Halasey, vice president for programs at InHealth and panel moderator. “Their forward-looking approaches are helping to create the research methodologies necessary to support good regulatory policy. In turn, those policies will benefit medtech investors and their companies—and the patients who gain access to their products.”

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