Medical Devices: Hearings ... Ninety-third Congress, First Session, on H. R. 6073 and H. R. 9984 ... October 23 and 24, 1973U.S. Government Printing Office, 1973 - 446 pages |
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Act is amended advisory committee agency amended by inserting American Dental Association ANSI application appropriate approval bill biofeedback cardiac pacemakers catheter Chairman class of device clinical Commission Congress Cosmetic Act criteria custom devices defective Dental Materials device manufacturers Drug Administration equipment established evaluation exemption experts Federal Food Food and Drug hazard hearing aids HUTT implants industry informed consent inserting or devices interest investigation labeling manufacturing practices Materials and Devices medical devices Medtronic ment Miss JOHNSON notify pacemakers paragraph patient PAUL G person pharmaceutical physician premarket clearance premarket testing prescribed problem procedures product development protocol promulgated proposed public health pursuant radiologic technologists recommendations records referred regulation regulatory risk ROGERS RYLEE safety and effectiveness safety and efficacy scientific review Secretary section 513 specific standards statement subcommittee submit subsection thereof tion United States Code X-ray