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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
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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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
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 Governing 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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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 engineers. 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president 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 Institute 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 Sciences 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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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
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
1
The 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.
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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.
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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
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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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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
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
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
