PREAMBLE COMPILATION MEDICAL DEVICES March 1936 - March 1978 SCP 16 12:1 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Rec. #63-781116 PUBL For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402 KF3827 M4M48 PUBL Laus ACKNOWLEDGMENT This publication was prepared under the overall direction of Agnes B. Black, Federal Register Writer, Food and Drug Administration, and the finished product reflects many diligent hours of preparation, review, and quality control by Lola Batson, Marcia Rosenburg, and other members of the FRW staff. 0366 FOREWORD All narrative preambles have been compiled from published FEDERAL REGISTER documents relating to the Medical Device Regulations of the Food and Drug Administration, and its administrative predecessors, from March 1936 through March 1978. Arranged to parallel the subject matter organization of Title 21 of the Code of Federal Regulations, this volume is part of a comprehensive effort to make available to the public and the agency a central source for tracing the historical development of agency regulations by subject. An agency User Review Committee conducts a technical oversight review of each volume and provides a potential user perspective to the decisionmaking process. This volume will be updated annually with a cumulative pocket supplement corresponding to the April 1 revision date of 21 CFR Chapter I. Notice of the availability of this and other volumes, as well as the pocket supplements, will be published in the FEDERAL REGISTER Upon printing. JERE E. GOYAN, Commissioner of Food and Drugs. |