Study Background

Study Title: " A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform”

Investigators: John Linehan, Ph.D.; Jan B. Pietzsch, Ph.D.

Research Advisory letter (pdf) from Northwestern University

Performance Period: 8/2010 - 7/2011                                                                           Webcast slides (survey overview, pdf)

This research studies opportunities for improving the FDA 510(k) product clearance process. The work builds on the investigators' previous research that documented in detail the medical technology development process (Stage-Gate Process for the Development of Medical Devices. Pietzsch JB, Shluzas LA, Paté-Cornell ME, Yock PG, Linehan JH. J. Med. Devices, v3, 021004-1 to 021004-15 (June 2009)).

The research team will undertake a systematic collection of information, data, and constructive input from those who participate in the 510(k) process and know it best—those involved in the design and development of regulated medical products, including entrepreneurs, academic physician-inventors, and federal regulators.

The study team is led by principal investigator John H. Linehan, PhD, professor of biomedical engineering at Northwestern University and consulting professor of Bioengineering at Stanford University. Collaborating in the study as co-investigator is Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering, core faculty member of the Biodesign program at Stanford University, and president and CEO of Wing Tech Inc.

The study has four main objectives as follows:

  • Build a body of knowledge that measures the current level of rigor and scrutiny that goes into assuring the safety and effectiveness of class II (510(k)) medical devices.
  • Elicit, from those closest to the device development and the 510(k) regulatory processes, the current elements that seem to work well, and how the process could be further strengthened.
  • Position and discuss the obtained findings in the context of the device development process. The objective is to clarify the implications and potential benefits and pitfalls of various proposed changes in the context of the device development process (e.g., increase/decrease of time to market; resource needs, etc.).
  • Collect data that elaborates and contrasts current regulation in the US in perspective with other regulatory systems, primarily the European CE process, and to analyze the implications with respect to the safety, effectiveness and availability of new medical devices.

The core element is a large-scale online survey, to be conducted mid-December 2010 through end-of-January 2011.