Medical Device Legislation Introduced in the 93d Congress, Prepared by the Staff ... , and Its Subcommittee on Public Health and Environment. August 19731973 - 153 pages |
Common terms and phrases
Act is amended adequate scientific evidence advisory committee amended by adding application was approved CARL ALBERT class of device clinical testing clinical trials compensation of employees conformity Cosmetic Act dealers or distributors defect or failure denying approval develop a proposed device or type device standard devices subject end thereof establish evaluation exemption experts failure to comply Federal agencies Federal Food Federal Register hazard health or safety HUDNUT III Identical provision Informed consent inserting or device interested persons investigation Judicial review lieu thereof manufacturing practice ment notice of completion notification offer to develop offeror prescribed prescription device prior procedures promulgate a standard promulgated under section proposed standard public health pursuant to subsection reasonable referred regulations respect revoke risk of illness safety and effectiveness Secre section 301 section 513 suant submit subparagraph subsection g thereof the following tion trade secret type or class United States Code
Popular passages
Page 66 - 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 47 - 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 50 - A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of new chemical additives which have not been adequately tested to establish their safety.
Page 75 - Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
Page 92 - Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.
Page 47 - Commissioner the establishment of a product class standard is necessary to reduce or eliminate unreasonable risk of illness or injury associated with exposure to or use of an in vitro diagnostic product...
Page 40 - As used in subparagraph (2) , the term "established name" with respect to a device means (A) the applicable official name of the device designated pursuant to section 508, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device.
Page 107 - ... 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 37 - Secretary is satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person...
Page 40 - If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 520(f)(1) or an applicable condition prescribed by an order under section 520(f)(2).