Classification of Transitional Devices Amendments Act of 1989

Summary

Classification of Transitional Devices Amendments Act of 1989 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to publish a notice in the Federal Register stating whether each transitional medical device for which a reclassification petition was not pending on January 1, 1989, shall remain in class III (devices requiring premarket approval) or be reclassified into class I (devices requiring general controls) or class II (devices requiring performance standards). Requires the manufacturers of devices that are to be classified in class I or II to submit to the Secretary any adverse safety and effectiveness information not previously reported. Requires the Secretary, within one year after enactment of this Act, to promulgate a regulation classifying each such device as class I or II, or providing that each such device shall remain in class III. Authorizes the Secretary to extend the one year period for classification for any such device for a period not to exceed one year. Prohibits the Secretary from retaining any daily wear nonhydrophilic plastic contact lens in class III unless such lens: (1) is used in supporting human life or preventing impairment of human health; or (2) presents an unreasonable risk of illness or injury.

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2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

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• Introduced in Senate

  summary · EN · 1 June 1989

  Open at official source

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