optimally protects patients and promotes innovation in support of public health and, if not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process. The committee is assembling materials that it will examine and discuss in developing its findings, conclusions, and recommendations. A final consensus report is expected to be released in the middle of 2011.

As part of its fact-finding process, the committee held the first of two public workshops on June 14–15, 2010, in Washington, DC, to gather information relevant to the statement of task. David Challoner, chair of the Institute of Medicine’s Committee on the Public Health Effectiveness of the FDA’s 510(k) Clearance Process, reminded participants that the committee has, as yet, made no conclusions, and that comments made by individuals, including members of the committee, should not be interpreted as positions of the committee or the IOM. In addition, committee members typically ask probing questions in IOM information-gathering sessions that may not be indicative of their personal views.

The following chapters summarize the presentations and panel discussions that occurred in the workshop. Chapter 2 provides an overview of the legislative history of the Medical Device Amendments of 1976, which instituted the 510(k) process. Chapter 3 focuses on FDA’s regulation of medical devices. A commissioned paper (Appendix C) on the premarket notification process, written by two former FDA Center for Devices and Radiological Health (CDRH) staff, was presented by one of its authors, and FDA’s compliance infrastructure was discussed by the current director of the CDRH Office of Compliance. The commercial medical device industry is the subject of Chapter 4. The structure of the industry’s innovation ecosystem was explained, and a second commissioned paper (Appendix D), on the impact of the regulatory framework on device innovation, was presented by its author, a former director of CDRH. After the presentations, a panel discussion expanded on the topic of balancing patient safety and innovation. The presentations and panel discussion in Chapter 5 offer a picture of the global regulatory environment of medical devices, including efforts toward global harmonization. Finally, as part of the committee’s fact-finding process, participants were offered the opportunity to make 5-minute statements on issues relevant to the committee’s task. Highlights of the public comments are presented in Chapter 6. The workshop agenda and biographic sketches of the speakers are in Appendixes A and B, respectively.



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