Medical Devices: Hearings, Ninety-third Congress, First Session ... |
Other editions - View all
Common terms and phrases
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
Popular passages
Page 297 - ... that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
Page 324 - Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 404 or 505, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce...
Page 297 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...
Page 71 - If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 506, and (2) such certificate or release is in effect with respect to such drug.
Page 320 - device" (except when used in paragraph (n) of this section and in sections 301 (i), 403 (f), 502 (c), and 602 (c)) means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.
Page 241 - A major objective of our association is to encourage the improvement of the health of the public and to promote the art and science of dentistry.
Page 320 - Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals...
Page 158 - My colleagues and I would be pleased to try to answer any questions you and other members of the subcommittee might have.
Page 297 - ... intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
Page 218 - ... consisting of adequate and well-controlled Investigations, Including clinical Investigations, by experts qualified by scientific training and experience to evaluate the effec-tiveness of the drug involved, on the basis of which it could fairly and re-sponsibly be concluded by such experts that the drug will have the effect It purports or is represented to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof.