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Introduction

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, also known as premarket notification (see Box 1-1). 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 legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. A predicate can be a device that has been cleared through the 510(k) process, a device that was legally marketed before May 28, 1976 (a preamendment device), a device that was originally on the US market as a Class III device (PMA) and later downclassified to Class II or I, or a 510(k)-exempt device (see Box 1-2). A device is considered substantially equivalent to a predicate if it has the same intended use as the predicate device and has either the same technologic characteristics as the predicate device or has different technologic characteristics but does not raise new questions of safety and effectiveness and is as safe and effective as the predicate (FDA, 2000).

As part of its fact-finding process, the IOM Committee on the Public Health Effectiveness of the FDA’s 510(k) Clearance Process planned two public workshops to gather information relevant to the statement of task. The committee’s statement of task is focused on the 510(k) clearance process. However, it is not possible to review the 510(k) process thoroughly in isolation from other components of medical-device regulation and oversight. Therefore, although some of the topics included in the workshops were not



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1 Introduction At the request of the Food and Drug Administration (FDA), the In- stitute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices, also known as premarket notification (see Box 1-1). 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 legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. A predicate can be a device that has been cleared through the 510(k) process, a device that was legally marketed before May 28, 1976 (a preamendment device), a device that was originally on the US market as a Class III device (PMA) and later downclassified to Class II or I, or a 510(k)- exempt device (see Box 1-2). A device is considered substantially equivalent to a predicate if it has the same intended use as the predicate device and has either the same technologic characteristics as the predicate device or has dif- ferent technologic characteristics but does not raise new questions of safety and effectiveness and is as safe and effective as the predicate (FDA, 2000). As part of its fact-finding process, the IOM Committee on the Public Health Effectiveness of the FDA’s 510(k) Clearance Process planned two public workshops to gather information relevant to the statement of task. The committee’s statement of task is focused on the 510(k) clearance pro- cess. However, it is not possible to review the 510(k) process thoroughly in isolation from other components of medical-device regulation and oversight. Therefore, although some of the topics included in the workshops were not 1

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2 THE FDA 510(k) CLEARANCE PROCESS BOX 1‑1 IOM Study on the Public Health Effectiveness of the FDA 510(k) Clearance Process The IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health. Specifically, the IOM committee will answer two principal questions: • Does the current 510(k) process optimally protect patients and pro- mote innovation in support of public health? • If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process? A final consensus report is expected to be released in the middle of 2011. BOX 1‑2 Definitions of Medical Device Classes Class I devices are subject to the least regulatory control. They pres- • ent minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class II devices are those for which general controls alone are in- • sufficient to ensure safety and effectiveness and for which existing methods are available to provide such assurances. Class III devices are those for which insufficient information exists • to ensure safety and effectiveness solely through general or special controls. Class III devices are usually those which support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. SOURCE: FDA, 2000. explicitly part of the 510(k) process, they are related to FDA’s ability to identify safety concerns about medical devices throughout their life cycle. The first workshop was held on June 14–15, 2010, in Washington, DC. At that workshop, information was presented to the committee regarding the legislative history of the Medical Device Amendments of 1976, which

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3 INTRODUCTION instituted the 510(k) process; the regulation of medical devices by FDA, including the premarket notification process and FDA’s compliance infra- structure; the structure of the medical-device industry innovation ecosystem and the effects of the regulatory framework on device innovation; and the global regulatory environment for medical devices, including efforts toward global harmonization (IOM, 2010). In addition, the committee heard brief statements from stakeholders on issues relevant to the committee’s task dur- ing a public comment period. The second workshop, summarized in this report, was held on July 28, 2010, in Washington, DC. Its primary focus was on monitoring the safety of marketed medical devices, including FDA’s postmarket surveillance activi- ties, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. The committee also heard a presentation on the issues associated with the use of computer software in medical devices and additional perspectives on device approval and clear- ance processes. This report summarizes the views expressed by workshop participants. Although the committee is responsible for the overall quality and accuracy of the report as a record of what took place at the workshop, the views contained in the report are not necessarily those of the committee. David Challoner, chair of the IOM committee, reminded participants that the committee is in the process of assembling materials that it will examine in the course of developing its findings, conclusions, and recom- mendations. The committee has drawn no conclusions thus far, and com- ments made by participants during the course of the workshop should not be interpreted as positions of the committee or of IOM. In addition, probing questions asked by committee members during IOM information-gathering sessions are not indicative of their personal views. ORGANIZATION OF THE REPORT The following chapters summarize the presentations and discussions at the second workshop. Chapter 2 reviews FDA’s postmarket surveillance activities, including the agency’s current system and future plans for moni- toring the safety of marketed devices, and product recall studies including a study commissioned for the committee. A variety of non-FDA efforts to monitor adverse events are associated with medical devices, and several such surveillance programs are discussed in Chapter 3. Chapter 4 summarizes an expert panel’s discussion of postmarket-surveillance issues. Chapter 5 includes three presentations on other topics of interest to the committee. The first is a presentation of a commissioned paper on the trustworthiness of software in devices; the paper itself is included in Appendix D. The second presentation is a review of quality concerns about the clinical data

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4 THE FDA 510(k) CLEARANCE PROCESS used in the PMA process. The last presentation is an example of industry concerns about transparency of, and delays in, FDA decision-making within the 510(k) process. The workshop agenda, biographic sketches of the speakers and pan- elists, and the two commissioned papers presented at the workshop are available as appendixes. REFERENCES FDA (Food and Drug Administration). 2000. Device Advice: Premarket Notification. Washington, DC, Food and Drug Administration. http://www.fda.gov/medicaldevices/ deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarket notification510k/default.htm (accessed August 31, 2010). IOM (Institute of Medicine). 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation. Edited by Wizemann, T. Washington, DC: The National Academies Press.