FDA Agrees to Downclassify CPR Aids, Membrane Lungs

The FDA Tuesday proposed moving external CPR aids and membrane lung devices from Class III to Class II, making them exempt from PMA filing. The reclassification of membrane lungs would apply to devices used when infants are at risk of imminent death or when, due to cardiopulmonary failure, a patient cannot be separated from cardiopulmonary bypass following surgery.
Devices & Diagnostics Letter