A bill to amend the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to determine the appropriate regulatory classification of transitional devices by the Medical Device Amendments of 1976, and for other purposes.
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.
Introduced in Senate
Read twice and referred to the Committee on Labor and Human Resources.
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