Food, Drug, and Device Amendments of 1985

Summary

Food, Drug, and Device Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to merge medical devices from two classes, one requiring general standards, the other requiring individual performance standards, into one class, authorizing the Secretary of Health and Human Services to establish a performance standard where necessary to assure safety or efficacy. Revises procedures for establishing medical device performance standards, reducing the time involved and the formality of the proceedings. Empowers the Secretary to obtain injunctions against the manufacturers and distributors of counterfeit drugs. Repeals the requirement that the Department of Health and Human Services certify batches of antibiotic drugs upon request by the manufacturer. Amends the Public Health Service Act to repeal electronic product radiation report requirements. Repeals the Filled Milk Act.

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1 official file

• Introduced in Senate

  summary · EN · 29 July 1985

  Open at official source

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