A bill to require the Secretary of Health and Human Services to determine the appropriate regulatory classification of the transitional devices of the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act and for other purposes.
Reclassification of Transitional Devices Amendments of 1986 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to reclassify devices placed in class III (devices requiring premarket approval) as a transitional measure into class I (devices requiring general controls) or into class II (devices requiring performance standards), except as specified. Permits the filing of objections by persons adversely affected by such reclassifications.
Introduced in Senate
Read twice and referred to the Committee on Labor and Human Resources.
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