1
Introduction1

At the request of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices.2 Also known as premarket notification, the process in Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already on the market, in which case the device does not need to go through the premarket approval process. The current 510(k) process, as written in statute and implemented by FDA, is intended to meet two primary goals: (1) to make safe and effective devices available to consumers and (2) to promote innovation in the medical device industry. Concern has been raised, however, that the 510(k) process permits inadequately tested devices to reach the market and thereby places the health of patients at risk. There are also concerns that there is a lack of predictability, consistency, and transparency in the process, potentially inhibiting innovation.

The IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will assess whether the 510(k) clearance process

1

The report summarizes the views expressed by workshop participants, and while the committee is responsible for the overall quality and accuracy of the report as a record of what transpired at the workshop, the views contained in the report are not necessarily those of the committee.

2

Further information about the committee is available at http://www.iom.edu/Activities/PublicHealth/510kProcess.aspx.



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1 Introduction1 At the request of the Food and Drug Administration (FDA), the Insti- tute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices.2 Also known as premarket notification, the process in Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already on the market, in which case the device does not need to go through the premarket approval process. The current 510(k) process, as written in statute and implemented by FDA, is intended to meet two primary goals: (1) to make safe and effective devices available to consumers and (2) to promote innovation in the medical device industry. Concern has been raised, however, that the 510(k) process permits inad- equately tested devices to reach the market and thereby places the health of patients at risk. There are also concerns that there is a lack of predict- ability, consistency, and transparency in the process, potentially inhibiting innovation. The IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will assess whether the 510(k) clearance process 1The report summarizes the views expressed by workshop participants, and while the com- mittee is responsible for the overall quality and accuracy of the report as a record of what transpired at the workshop, the views contained in the report are not necessarily those of the committee. 2Further information about the committee is available at http://www.iom.edu/Activities/ PublicHealth/510kProcess.aspx. 1

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 THE FDA 510(k) ClEARANCE PROCESS 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 commit- tee 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 in- formation 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 discus- sions 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 innova- tion. 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 state- ments 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.