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# Regulatory Review for Sedasys System
- URL: https://www.fdaweb.com/regulatory-review-for-sedasys-system/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140703

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Scott Laboratories’ Sedasys System is 2,816 days. Of this time, 950 days occurred during the testing phase and 1,866 days during the approval phase. The device is indicated for intravenous administration of 1% propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-07/pdf/2018-02432.pdf?ref=fdaweb.com).