legislation: 100-s-1808
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| bill_id | congress | bill_type | bill_number | title | policy_area | introduced_date | latest_action_date | latest_action_text | origin_chamber | sponsor_name | sponsor_state | sponsor_party | sponsor_bioguide_id | cosponsor_count | summary_text | update_date | url |
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| 100-s-1808 | 100 | s | 1808 | Classification of Transitional Devices Amendments Act of 1988 | Health | 1987-10-22 | 1988-10-06 | Placed on Senate Legislative Calendar under General Orders. Calendar No. 1119. | Senate | Sen. Bumpers, Dale [D-AR] | AR | D | B001057 | 8 | (Reported to Senate from the Committee on Labor and Human Resources with amendment, S. Rept. 100-588) Classification of Transitional Devices Amendments Act of 1988 - 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 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 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. | 2025-04-21T12:24:17Z | https://www.congress.gov/bill/100th-congress/senate-bill/1808 |