Medical Devices Safety Act

Summary

Medical Devices Safety Act - Title I: The National Medical Devices Commission - Establishes the National Medical Devices Commission to determine the manner and extent to which there should be Federal regulation of manufacturing of medical devices. Directs the Commission to submit to the President and the Congress such interim and final reports as it deems appropriate. Requires the Secretary of Health, Education, and Welfare to submit to the President and the Congress his views on the Commission's report. States that the Commission shall terminate not later than two years from the effective date of this Act or thirty days after it has submitted its final report, whichever occurs earlier. Sets forth the powers of the Commission. States that the Commission shall, to the extent practicable, utilize the services of the Department of Health, Education, and Welfare. Title II: Amendments to the Federal Food, Drug, and Cosmetic Act - States that a device shall be deemed to be adulterated for the purposes of the Federal Food, Drug, and Cosmetic Act, if the methods used in, or the facilities or control used for, its manufacturing, processing, packing, holding, or installation do not conform to, or are not operated or administered in conformity with, current food manufacturing practice. States that every person engaged in manufacturing, processing, or distributing, or who uses in a professional manner, a device that is subject to this Act shall establish and maintain records, and make written reports to the Secretary, of data relating to clinical experience obtained by that person with respect to the device and bearing on the safety, reliability, or effectiveness of the device. Establishes standards under which the Secretary may, after due notice and opportunity for hearing to the manufacturer, issue an order to remove a device from being sold on the market. Authorizes the device manufacturer to appeal an order by the Secretary removing the device from sale on the market by filing in the United States court of appeals for the circuit in which the manufacturer resides or at his principal place of business. Directs the Secretary to promulgate regulations for exempting from this Act devices intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of devices. Title III: Miscellaneous - Establishes the National Medical Devices Information Center to establish workshops, clinics, and other educational programs to train and educate doctors, hospital personnel, technicians, and other possible operators of medical devices in the use and testing of such devices. States that this Act shall take effect on the first day of the thirteenth calendar month following the month in which this Act is enacted.

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1 official file

• Introduced in House

  summary · EN · 5 September 1973

  Open at official source

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