PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS

Measuring Postmarket Performance and Other Select Topics

Workshop Report

Theresa Wizemann, Editor

Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington D.C.
www.nap.edu



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Theresa Wizemann, Editor Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by a contract between the National Academy of Sciences and the US Department of Health and Human Services (HHSF223200810020I, TO 13). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the agency that provided support for this project. International Standard Book Number-13: 978-0-309-16206-7 International Standard Book Number-10: 0-309-16206-8 Additional copies of this report are available from the National Academies Press, 500 Fifth Street NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap. edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2011. Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON THE PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS1 DAVID CHALLONER (Chair), Vice President for Health Affairs, Emeritus, University of Florida, Gainesville, FL GARY S. DORFMAN, Professor and Vice Chair for Research, Weill Cornell Medical College, New York, NY BARBARA EVANS, Associate Professor; Codirector, Health Law & Policy Institute; Director, Center on Biotechnology and Law, University of Houston Law Center, Houston, TX LAZAR GREENFIELD, Professor of Surgery and Chair Emeritus, University of Michigan, Ann Arbor, MI STEVEN GUTMAN, Associate Director, BlueCross BlueShield Assocation, Alexandria, VA YUSUF M. KHAN, Assistant Professor, University of Connecticut Health Center, Farmington, CT DAVID KORN, Vice Provost for Research, Harvard University, Boston, MA ELIZABETH W. PAXTON, Director of Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, CA SHARI LAWRENCE PFLEEGER, Director of Research, Institute for Information Infrastructure Protection, Washington, DC WILLIAM W. VODRA, Senior Counsel (Retired), Arnold & Porter, LLP, Washington, DC BRIAN WOLFMAN, Visiting Professor of Law, Georgetown University Law Center, Washington, DC KATHRYN C. ZOON, Scientific Director and Director of the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD Study Staff ABIGAIL E. MITCHELL, Study Director HEATHER M. COLVIN, Program Officer KATHLEEN M. McGRAW, Senior Program Assistant NORMAN GROSSBLATT, Senior Editor ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice 1The role of the Committee on Public Health Effectiveness of the FDA 510(k) Clearance Process was limited to planning an information-gathering public workshop. This workshop summary has been prepared by the workshop editor as a factual summary of the presentations and discussions that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, are not necessarily endorsed or verified by the committee, and should not be construed as reflecting any group consensus. v

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Reviewers This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following for their review of this report: Richard DeRisio, Abbott Medical Optics Larry Kessler, School of Public Health, University of Washington John S. Rumsfeld, Veterans Health Administration Terrence J. Sweeney, Philips Healthcare Susan F. Wood, School of Public Health and Health Services, The George Washington University Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of the report was overseen by Kristine M. Gebbie, Acting Joan Grabe Dean of the School of Nursing, Hunter College at the City University of New York. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests with the authors and the institution. vii

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Contents ABBREVIATIONS xiii 1 INTRODUCTION 1 2 FOOD AND DRUG ADMINISTRATION POSTMARKET SURVEILLANCE ACTIVITIES AND RECALL STUDIES OF MEDICAL DEVICES 5 3 NON–FOOD AND DRUG ADMINISTRATION SOURCES OF ADVERSE EVENT DATA 23 4 POSTMARKET SURVEILLANCE OF MEDICAL DEVICES: PANEL DISCUSSION 39 5 OTHER SELECT TOPICS 47 APPENDIXES A Workshop Agenda 61 B Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers 65 C 510(k) Premarket Notification Analysis of FDA Recall Data 73 D Trustworthy Medical Device Software 97 ix

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x CONTENTS TABLES, FIGURES, AND BOXES Tables 2-1 Primary Reason for 118 Class I Recalls, 18 C-1 Number of Recalls per 510(k), 82 C-2 Causes of 510(k) Recalls, 86 C-3 Medical Device Reporting and 510(k)s, 93 D-1 Examples of Adverse Events Where Medical Device Software Played a Significant Role, 99 Figures 2-1 Breakdown of advisory-committee assignments for 510(k) submissions in 1996–2009, 12 3-1 Statistical methods used in the DELTA System, 35 3-2 Prospective DELTA Network Study, 36 C-1 Annual number of 510(k) applications, 76 C-2 Advisory committee assignments for submitted 510(k)s, 77 C-3 510(k) device classification, 78 C-4 510(k) type, 1996–2009, 79 C-5 510(k) implantable and life-sustaining features, 2003–2009, 80 C-6 Annual number of unique 510(k)s affected by recall, 81 C-7 Year of 510(k) decision for recalls occurring in 2003–2009, 83 C-8 Recall-free 510(k) “survival,” 2003–2009, 84 C-9 Annual 510(k) recall rate based on years since decision, 85 C-10 Impact of predicate number on 510(k) recalls, 2004–2009, 87 C-11 Impact of predicate age on 510(k) recalls, 2004–2009, 88 C-12 Impact of 510(k) type on recall rate, 2003–2009, 89 C-13 Association of 510(k) features with recall rate, 2003–2009, 90 C-14 Device classification and 510(k) recall rate, 2003–2009, 91 C-15 Association of advisory committee assignments with 510(k) recall rate, 2003–2009, 92 C-16 Medical device reporting and recalls, 94

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xi CONTENTS Boxes 1-1 IOM Study on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2 1-2 Definitions of Medical Device Classes, 2 2-1 Types of Device Hazards, 7 2-2 Maisel’s Key Findings: Analysis of FDA Recall Data, 15 2-3 Hall’s Key Findings: Using Recall Data to Assess the 510(k) Process, 20 3-1 NCDR Registries, 24

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Abbreviations AED automatic external defibrillator CART Clinical Assessment, Reporting, and Tracking program CDRH Center for Devices and Radiological Health (FDA) CE Mark European conformity mark CHMP Committee for Human Medicinal Products CMS Centers for Medicare and Medicaid Services EMA European Medicines Agency FDA US Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act GHTF Global Harmonization Task Force GRAE generally recognized as effective GRAS generally recognized as safe ICD implantable cardioverter–defibrillator IDE investigational device exemption ISO International Organization for Standardization MAUDE Manufacturer and User Facility Device Experience Database MDA Medical Device Amendments of 1976 MDR medical-device reporting xiii

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xiv ABBREVIATIONS NCDR National Cardiovascular Data Registry NSE not substantially equivalent PMA premarket approval QSR quality system review SSED Summary of Safety and Effectiveness Data UDI unique device identification VA US Department of Veterans Affairs VHA Veterans Health Administration