An Index of United States Federal Regulations and Guidelines Which Cover Safety Surveillance of Medical Devices
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
AN INDEX OF UNITED STATES FEDERAL REGULATIONS AND GUIDELINES WHICH COVER SAFETY SURVEILLANCE OF MEDICAL DEVICES CHARLES F. CURRAN, PHD Manager, Research and Development QA/QC/Compliance, Fujisawa USA, Inc., Deerfield, Illinois
JUDITHM. SILLS,PHARMD Senior Director, Drug Safety Surveillance and Information, Warner-Lambert Company, Morris Plains, New Jersey
An index is provided of relevant sections of Title 21 of the Code of Federal Regulations which cover the safety surveillance of medical devices which are required of manufactures in the United States. A relevant guideline prepared by the Food and Drug Administration is also indexed. Key Words: United States regulations; Medical device safety; Code of Federal Regulations
INTRODUCTION THIS IS AN INDEX of the United States federal regulations governing safety surveillance of medical devices. It is intended to assist in locating the specific sections of the regulations which cover the various activities required of medical device manufacturers and other affiliates in the receiving, processing, and filing of safety information, and in the reporting of safety information to the Food and Drug Administration (1,2). This index is not endorsed by any regulatory agency or outside organization and is offered to facilitate familiarization with applicable and proposed United States federal regulations. Use of this guide is not intended to be a substitute for a careful and thorough review of applicable United States federal
Reprint address: Charles F. Curran, PhD, Fujisawa USA, Inc., Three Parkway North, Deerfield, IL 600152548.
regulations governing safety surveillance of medical devices.
DISCUSSION Title 21 of the Code of Federal Regulations governs safety surveillance of medical devices and the Federal Register is the medium by which new or revised rules and regulations are implemented. The reader is directed to the preamble sections which typically accompany newly-implemented or proposed regulations in the Federal Registel: Preambles outline the intent of each new rule or regulation and contain the regulatory agency’s responses to comments made by outside individuals and groups during earlier phases of the rulemaking process. Careful reading of the comments and responses found in preambles is highly recommended as a source of useful insights into the context, meaning, intent, and scope of the regulation. Guidelines prepared by the FDA provide
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Charles F. Curran and Judith M.Sills
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TABLE 1 Regulations Pertaining to Medical Device Reporting Alternative reporting requirements, 803.19, March 1997 Guideline, pp. 21-23 Annual baseline update, 803.55(b), March 1997 Guideline, pp. 15-1 6 Annual certification, 803.57, March 1997 Guideline, pp. 6, 7, 17, 20 Baseline reports, 803.55, March 1997 Guideline, pp. 13-16, 20 Baseline reports linked to 5-day reports, March 1997 Guideline, p. 15 Baseline reports on systems with multiple com
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