PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS
Balancing patient Safety and Innovation
Theresa Wizemann, Editor
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
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 (HH5F223200810020I, 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: 978-0-309-15849-7
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Suggested citation: IOM (Institute of Medicine). 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press.
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.
COMMITTEE ON THE PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS
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;
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,
Technical Evaluation Center, Blue Cross/Blue Shield, Alexandria, VA
YUSUF M. KHAN, Assistant Professor,
University of Connecticut Health Center, West Hartford, 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, Hanover, NH
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
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
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:
Robert J. Genco, State University of New York at Buffalo
Theodore S. Lawrence, University of Michigan Medical School
John H. Linehan, Northwestern University
Patricia B. Shrader, Becton, Dickinson and Company
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of this report before its release. The review of the report was overseen by Enriqueta C. Bond, Burroughs Wellcome Fund. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests with the authors and the institution.
CDRH Center for Devices and Radiological Health (FDA)
CE Mark European Conformity mark
CHMP Committee for Human Medicinal Products
CLIA Clinical Laboratory Improvement Amendments
EMA European Medicines Agency (formerly EMEA)
FDA US Food and Drug Administration
FDAMA FDA Modernization Act
FFDCA Federal Food, Drug, and Cosmetic Act
GHTF Global Harmonization Task Force
GMP good manufacturing practice
GRAE generally recognized as effective
GRAS generally recognized as safe
HDE humanitarian device exemption
IDE investigational device exemption
IFU instructions for use
ISO International Organization for Standardization
IVD in vitro diagnostic
LBT lab-based tests