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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

MEDICAL DEVICES
AND THE
PUBLIC’S HEALTH

THE FDA 510(k) CLEARANCE PROCESS AT 35 YEARS

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. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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 study was supported by Contract No. HHSF223200810020I, Task Order #13 between the National Academy of Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-21242-7

International Standard Book Number-10: 0-309-21242-1

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., 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. Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”

                                                                  —Goethe

image

INSTITUTE OF MEDICINE
          OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

DAVID R. CHALLONER (Chair), Vice President for Health Affairs, Emeritus, University of Florida, Gainesville, FL

GARY S. DORFMAN, Professor and Vice Chair for Research, Department of Diagnostic Radiology, 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 J. GREENFIELD, Professor of Surgery and Chair Emeritus, University of Michigan, Ann Arbor, MI

STEVEN GUTMAN, Associate Director, Technology Evaluation Center, BlueCross BlueShield Association, 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, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD

Consultant to the Committee

SUSANNE LUDGATE, Clinical Director, Medicines and Healthcare Products Regulatory Agency, UK

Study Staff

ABIGAIL E. MITCHELL, Study Director

HEATHER M. COLVIN, Program Officer

MELISSA G. FRENCH, Associate Program Officer

KATHLEEN M. SHEPHERD, Senior Program Assistant

NORMAN GROSSBLATT, Senior Editor

ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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 for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individual’s for their review of this report:

Halyna Breslawec, Cosmetic Ingredient Review

Paul Citron, Medtronic, Inc. (retired)

Khaled El Emam, University of Ottawa

Ellen Flannery, Covington & Burling, LLP

Thomas Fogarty, Fogarty Engineering

Gordon Gillerman, National Institute of Standards and Technology

George Isham, HealthPartners, Inc.

Alan Kent, Global Harmonization Task Force

Arthur Levin, Center for Medical Consumers

Mark B. McClellan, The Brookings Institution

Richard Merrill, University of Virginia

Richard Platt, Harvard Medical School

Miriam Provost, Biologics Consulting Group, Inc.

Fran Visco, National Breast Cancer Coalition

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by Edwin P. Przybylowicz, Eastman Kodak (retired) and Brian L. Strom, University of Pennsylvania School of Medicine. Appointed by the National Research Council and Institute of Medicine, respectively, they were 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 entirely with the author committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Acknowledgments

The committee thanks everyone who presented and participated in panel discussions during the public workshops, informing our task and assisting in developing our approach and thought process on the statement task. The following individuals presented information at the workshops: David Feigal, Arizona State University School of Law; Robert Fischell, Neuralieve, Inc.; Kevin Fu, Department of Computer Science, University of Massachusetts, Amherst; Susan Gardner, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA); Ralph Hall, University of Minnesota Law School; Peter Barton Hutt, Covington and Burling, LLP; David Jeffrys, Eisai Europe Ltd.; William Maisel, formerly with the Medical Device Safety Institute (now with the FDA); Josh Makower, ExploraMed Development, LLC; Frederick Masoudi, Denver Health Medical Center; Eric Peterson, Division of Cardiology, Duke University Medical Center; Philip Phillips, PCS, LLC; Rita Redberg, Division of Cardiology, University of California, San Francisco; Frederic Resnic, Brigham and Women’s Hospital; Janet Trunzo, AdvaMed; Timothy Ulatowski, CDRH; and Paul Varosy, Department of Veterans Affairs (VA) Eastern Colorado Health Care System. Doug Mowen, of PricewaterhouseCoopers, was unexpectedly unable to present at the June 2010 workshop but provided materials for the committee’s review. Many of the presenters also participated in the panel discussions. Other panel discussants whom the committee thanks are Amy Allina, National Women’s Health whom; Susan Alpert, Medtronic, Inc.; D. Bruce Burlington, independent consultant; Larry Kessler, University of Washington School of Public Health; and William Vaughan, consultant to Consumer’s Union.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

The committee thanks the representatives of the FDA who provided helpful information on CDRH, medical-device regulation, and various aspects of the 510(k) clearance process: Philip Desjardins, Maggie Dietrich, Ann Ferriter, Christy Foreman, Heather Rosecrans, Donna-Bea Tillman, and Jeffrey Shuren.

The committee thanks the authors of the commissioned papers: David Feigal, Arizona State University School of Law; Kevin Fu, Department of Computer Science, University of Massachusetts, Amherst; Larry Kessler, University of Washington School of Public Health; William Maisel, Medical Device Safety Institute; and Philip Phillips, PCS, LLC. The papers were an excellent resource of information and proved to be very helpful. All affiliations were contemporaneous.

The committee thanks members of the public who provided oral comments during the public meetings and persons and organizations that submitted written materials and comments. There was a wide variety of points of view in the commentary, and those viewpoints afforded valuable insight into the complexity of the process and its outcomes. The time and effort made in traveling to the public meetings and in preparing written materials and statements were greatly appreciated.

The committee also thanks Katharine Larson and Lindsay S. Narvaez, students at the University of Houston Law Center, for their assistance in researching and formatting legal citations.

The committee thanks those who provided a critical perspective of the European system of device regulation: Susanne Ludgate, of the Medicines and Healthcare Products Regulatory Agency (UK), served as a consultant to the committee, and Christopher Hodges, of the University of Oxford, also provided extremely valuable insight into the European Union’s medical-device regulatory system.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Preface

The vast majority of the medical devices used in health care in the United States that are reviewed by the US Food and Drug Administration (FDA) before entering the marketplace are cleared (not approved) for human use in a process called premarket notification, or the 510(k) clearance process, named after Section 510(k) of the authorizing legislation passed by Congress in 1976. Stimulated by reports of problems with several 510(k)-cleared devices, the public, legislators, the Government Accountability Office, the Department of Health and Human Services Office of the Inspector General, and the courts, including the Supreme Court, have all questioned the logic and value of the 510(k) clearance process being used by a federal agency charged with responsibility for protecting and promoting the public’s health. After 35 years, at a time of rapidly changing science and technology, questions persist about whether the 510(k) process is protecting and promoting the public’s health. Thus, the FDA asked the Institute of Medicine (IOM) to evaluate the 510(k) clearance process and to make recommendations aimed at protecting the health of the public while preserving the legitimate interests of industry and patients by making available a mechanism to achieve timely access of medical devices to the market.

The committee determined that it could not evaluate the 510(k) clearance process for bringing devices to market in isolation; it was necessary to understand the full spectrum of devices reviewed by the FDA—from the simplest tongue depressor to the most complex implantable devices. The 510(k) clearance process, the mechanism used for premarket review of most Class II devices, is embedded in the vast middle. In reviewing the legislative and regulatory history of the 510(k) program, the committee found that it was designed in 1976 to provide only a determination of the substantial equiva-

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

lence of a new device to an already marketed (predicate) device; it was not designed to determine whether a new device provides a reasonable assurance of safety and effectiveness or whether it promotes innovation. That finding complicated the committee’s work in that the FDA, in the charge to the committee, stated that the goals of the 510(k) clearance process are to “make available to consumers devices that are safe and effective” and to “promote innovation in the medical device industry.” The committee struggled with how to address the conflict between the legislative framework of the program and the FDA’s stated goals.

The report lays out the committee’s rationale and approach for addressing this conflict and provides recommendations to the FDA that it believes will result in an improved regulatory system for bringing Class II medical devices to market. The recommendations are focused on strengthening the science base needed to make better-informed regulatory decisions and on giving the FDA the tools that it needs to identify and remove problematic devices from the market. The committee believes that taking the recommended steps will generate the information needed to design a robust regulatory framework for Class II devices. The new framework would increase the public’s confidence that safe and effective medical devices are being made available in a timely manner.

Because of the high visibility of concerns about the 510(k) clearance process, the FDA has undertaken its own internal study in parallel with the IOM study to determine how the process might be improved within the FDA’s existing legislative authorities. Although IOM was not specifically charged with weighing in on or critiquing the FDA’s recommendations, the committee did use the FDA’s data and analyses in reaching its own conclusions and recommendations.

I would like to thank the members of the committee for their incredibly hard work over the past 16 months. They came from very different backgrounds and perspectives on the development and use of devices for human health care. The time that the committee members invested in this study was considerable. Although their discussions and deliberations often were spirited, they collaborated effectively and reached consensus on the findings, conclusions, and recommendations.

Finally, the committee thanks the IOM staff, including the study director, Abigail Mitchell; the program officer, Heather Colvin; the associate program officer, Melissa French; and the senior program assistant, Kathleen Shepherd. The staff’s efforts were essential in the information-gathering and writing process, and in providing the committee with necessary assistance and support.

David R. Challoner, Chair
Committee on the Public Health Effectiveness of the
FDA 510(k) Clearance Process

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Acronyms and Abbreviations

AIMDD

active implantable medical devices

ALJ

administrative law judge

CA

competent authority

CART

Clinical Assessment, Reporting, and Tracking program

CBER

Center for Biologics Evaluation and Research

CDER

Center for Drug Evaluation and Research

CDRH

Center for Devices and Radiological Health

CEN

European Committee for Standardization

CFR

Code of Federal Regulations

CMS

Centers for Medicare and Medicaid Services

DEN

Device Experience Network

DELTA

Data Extraction and Longitudinal Time Analysis

DHR

device history record

EHR

electronic health record

EU

European Union

FDA

Food and Drug Administration

FDAAA

Food and Drug Administration Amendments Act

FDAMA

Food and Drug Administration Modernization Act

FFDCA

Federal Food, Drug, and Cosmetic Act

FTC

Federal Trade Commission

FTE

full-time equivalent

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

FY

fiscal year

GAO

Government Accountability Office (formerly General Accounting Office)

GHTF

Global Harmonization Task Force

GMP

good manufacturing practices

HHS

Department of Health and Human Services (formerly Department of Health, Education, and Welfare)

HIMA

Health Industry Manufacturers Association

IG

inspector general

IOM

Institute of Medicine

IVDD

in vitro diagnostic medical devices

MAUDE

Manufacturer and User Device Experience database

MD EPINET

Medical Device Epidemiology Network

MDA

Medical Device Amendments

MDR

medical-device report

MedSun

Medical Product Surveillance Network

NB

notified body

NCDR ICD

National Cardiovascular Data Registry for implantable cardioverter defibrillators

NDA

new drug application

NSE

not substantially equivalent

OC

Office of Compliance

OCP

Office of Combination Products

ODE

Office of Device Evaluation

OMB

White House Office of Management and Budget

ORA

Office of Regulatory Affairs

OTS

off-the-shelf

PMA

premarket approval

QSR

quality-system regulations

SE

substantially equivalent

SMDA

Safe Medical Devices Act

STED

summary technical document

UDI

unique device identification

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market.

At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

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