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SAFE MEDICAL DEVICES FOR CHILDREN
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SAFE MEDICAL DEVICES FOR CHILDREN
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We hope that this report will put a face on the children who benefit every day from medical devices, lend a voice to some of the challenges they face in realizing the benefits of the devices, and give heart to those who want to make things even better. In spirit, our report is for these children and their families. As written, this report responds to a request from Congress to investigate the questions described in the Summary and Chapter 1, and we have aimed much of our analysis and recommendations at legislative and administrative policymakers and those who advise them. At the same time, we have also tried. | INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES SAFE MEDICAL DEVICES FOR CHILDREN SAFE MEDICAL DEVICES FOR CHILDREN Committee on Postmarket Surveillance of Pediatric Medical Devices Board on Health Sciences Policy Marilyn J. Field and Hugh Tilson Editors INSTITUTE OF MEDICINE Of THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington DC www.nap.edu 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. 223-01-2460 Task Order No. 11 between the National Academy of Sciences and the U.S. Food and Drug Administration. 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 the project. Library of Congress Cataloging-in-Publication Data Institute of Medicine U.S. . Committee on Postmarket Surveillance of Pediatric Medical Devices. Safe medical devices for children Committee on Postmarket Surveillance of Pediatric Medical Devices Board on Health Sciences Policy Marilyn J. Field and Hugh Tilson editors Institute of Medicine of the National Academies. 1st ed. p. cm. This study was supported by Contract No. 223-01-2460 Task Order No. 11 between the National Academy of Sciences and the U.S. Food and Drug Administration. ISBN 0-309-09631-6 hardcover 1. Pediatrics Equipment and supplies Standards United States. 2. Pediatrics United States Equip-ment and supplies Evaluation. DNLM 1. Product Surveillance Postmarketing standards Child United States. 2. Equipment Safety
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