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# Review Period Determined on Lung Donor Device
- URL: https://www.fdaweb.com/review-period-determined-on-lung-donor-device/
- Published: 2021-03-16T12:00:00.000Z
- Updated: 2026-09-14T16:51:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148885

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for TransMedics’ OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double-lung transplantation. The review period was determined to be 2,341 days, which includes 1,672 days that occurred during the testing phase and 669 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-16/pdf/2021-05372.pdf?ref=fdaweb.com).