Food, Drug, and Device Amendments of 1985

Summary

Food, Drug, and Device Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to combine into a single class I those medical devices currently in class I (for which general controls are sufficient) and class II (for which performance standards are required). Redesignates current class III devices (devices for which premarket approval is required) as class II. Revises procedures for establishing medical device performance standards. Authorizes the Secretary of Health and Human Services to establish performance standards for any medical device regardless of its classification. (Under present law, the Secretary may establish performance standards only for class II devices.) Authorizes the Secretary to establish standards by informal notice-and-comment rulemaking in consultation with an appropriate advisory committee. Allows the Secretary to obtain injunctions against the manufacture and distribution of counterfeit drugs and the making, selling, or concealing of the equipment used to make counterfeit drugs. Repeals the requirement that the Secretary, upon request of a manufacturer, certify batches of antibiotics for conformity to applicable standards of identity strength, quality, and purity. Amends the Public Health Service Act to repeal requirements that the Secretary: (1) study and report to the Congress on State and Federal control of health hazards from electronic product radiation; and (2) submit an annual report on the administration of the electronic product radiation control program. Repeals the Filled Milk Act.

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1 official file

• Introduced in House

  summary · EN · 23 April 1985

  Open at official source

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