Institute for Health Technologies Studies: Comprehensive Analysis of the FDA 510(k) Process

In light of the recent changes to the Food and Drug Administration’s (FDA) 510(k) process—the most commonly-used pathway to market for medical devices—a team of from Northwestern and Stanford universities are undertaking systematic collection of input from individuals involved in the design and development of medical products. The study aims to shed light on opportunities for improving FDA product review process.

The researchers have created an online survey intended to produce a statistically valid foundation for improving the product review process and to guide the development of new policies that will benefit medtech investors, companies, and patients alike.

 The survey is part of “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” a study funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

Principal investigator John H. Linehan, PhD, professor of biomedical engineering at Northwestern University, will lead the study along with collaborator Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering and an advisory faculty member of the Biodesign program at Stanford University, and president and CEO of Wing Tech Inc., a technology consultancy.

In a recent webcast, “Industry, Agency, and the 510(k) Process: An Industrywide Survey,” the investigators discussed the regulatory background and context for the study. Other webcast participants included Larry G. Kessler, ScD, professor and chair of health services at the University of Washington (formerly director of FDA’s Office of Surveillance and Biometrics), and Paul LaViolette, MBA, venture partner with SV Life Sciences (formerly chief operating officer at Boston Scientific).

Additionally, InHealth sponsored a special panel session at OneMedForum San Francisco 2011 featuring investigators who have recently conducted studies of FDA’s 510(k) process. Video segments from the session can be accessed by visiting the InHealth website at www.inhealth.org.

Individuals with recent experience of the 510(k) process are being sought to participate in the industrywide survey by visiting the study’s website at www.510k.net. 

The roughly 90-question anonymous electronic survey is geared toward individuals and companies that have been involved in developing a 510(k) product in the past three years, including entrepreneurs, academic physician-inventors, product developers, and regulatory affairs experts. The survey takes approximately 45–60 minutes and must be completed by January, 31, 2010.

To learn more about the study and participate in the 510(k) survey, visit www.510k.net.