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# FDA Reclassifies Membrane Lung Devices
- URL: https://www.fdaweb.com/fda-reclassifies-membrane-lung-devices/
- Published: 2016-02-12T12:00:00.000Z
- Updated: 2026-09-15T02:35:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134761

*Federal Register* Final order: FDA is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments Class 3 device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to Class 2 (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-02-12/pdf/2016-02876.pdf?ref=fdaweb.com)