Preamble Compilation: Medical Devices, March 1936-March 1978U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1981 - 420 pages |
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Common terms and phrases
52 Stat 5600 Fishers Lane additional aerosol agency application bons cation chloro chlorofluoro chlorofluorocar chlorofluorocarbon chlorofluorocarbon propellants classification Commis Commissioner agrees Commissioner believes Commissioner of Food contact lenses Cosmetic Act secs Dalkon Shield Drug Administration drug products effective date environmental establish Federal Food FEDERAL REGISTER Filed final regulation fluorocarbons Food and Drug halocarbons hearing aid Hearing Clerk hydrochlorofluorocarbons impact impact-resistant lenses intended intraocular lenses intrauterine devices investigational device investigational device exemption investigational study IUD's labeling lens manufacturers medical devices ments metic notice ozone depletion Packaging and Labeling panel patient petition phaseout physician posed premarket approval premarket notification procedures prod proposed regulation published pursuant quired quirements request requirements risk safety and effectiveness self-pressurized containers sion sioner specific sponsor standards stratospheric stratospheric ozone submission submitted Subpart tion tional tive ucts
Popular passages
Page 321 - 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 321 - new drug" means — (1) Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 312 - The voluntary consent of the human subject is absolutely essential. 'This means that the person involved should have legal capacity to give consent ; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion...
Page 29 - January 25, 1977, submit to the Hearing Clerk, Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20857, written comments (preferably in quintuplicate and identified with the Hearing Clerk docket number found in brackets in the heading of this document) regarding this notice.
Page 385 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 283 - ... which does not achieve any of its principal 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 4 - Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease...
Page 73 - Part 1 Regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Page 116 - Register file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 5440, 330 Independence Avenue SW., Washington 25, DC, written objections thereto.
Page 278 - The Commissioner has carefully considered the environmental effects of the proposed regulations and, because the proposed action will not significantly affect the quality of the human environment, has concluded that an environmental impact statement is not required. A copy of the environmental impact assessment is on file with the Hearing Clerk, Food and Drug Administration.