Gmp boas practicas formedical device quality systems manual

HHS Publication FDA 97-4179

MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE

First Edition (Supersedes the Medical Device Good Manufacturing Practices Manual)
Andrew Lowery, Judy Strojny, and Joseph Puleo Division of Small Manufacturers Assistance Office of Health and Industry Programs

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

CDRH
December 1996 (This publication supersedes FDA 91-4179)

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration
Center for Devices and Radiological Health Rockville, Maryland 20850

FOREWORD

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices, to control unnecessary human exposure to potentially hazardous ionizing and non-ionizing radiation, and to assure the safe, efficacious use of such radiation. The Center publishes the results of its work in scientific journals and in its own technical reports. These reports disseminate results of CDRH and contractor projects. They are sold by the Government Printing Office and/or the National Technical Information Service. Many are available via the FDA home page on the World Wide Web at: http:\\www.fda.gov. We welcome your comments and requests for further information.

D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health

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PREFACE

The Medical Device Amendments of 1976 mandated the establishment of "an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act." The Division of Small Manufacturers Assistance (DSMA) in the Office of Health and Industry