Medical Device Amendments of 1982

Summary

Medical Device Amendments of 1982 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to consider relevant safety data and voluntary standards developed by private organizations in establishing performance standards for medical devices. Authorizes the Secretary, after consultation with appropriate classification panels, to amend or revoke any performance standard prescribed under such Act. Revises the procedures for proposed rulemaking for performance standards for medical devices. Requires medical device manufacturers to inform the Secretary of the presence of unreasonable risks to public health in devices intended for human use. Repeals the prohibition on the use in labeling or advertising of representations concerning Food and Drug Administration approvals. Repeals the Filled Milk Act which prohibits the sale of imitation milk.

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1 official file

• Introduced in House

  summary · EN · 19 August 1982

  Open at official source

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