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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

THE NATIONAL ACADEMIES PRESS
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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.

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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.

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

“Knowing is not enough; we must apply.

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INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES


Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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.


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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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.

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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.

Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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Page xiii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×

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

Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
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Page R3
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R4
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
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Page R6
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R8
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R9
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R10
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R11
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
Page R13
Suggested Citation:"Front Matter." 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. doi: 10.17226/13020.
×
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The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. 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.

As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information.

Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

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