Zdrowie i gospodarka · 06/04/2006

FDA Proposes to Reclassify Topical Oxygen Chamber for Extremities from Class III to Class II

The FDA is proposing to reclassify the topical oxygen chamber for extremities, a device that surrounds a patient's limb and applies humidified oxygen to aid healing of chronic skin ulcers, from a class III premarket approval device to a class II device with special controls, and is publishing a draft guidance document to support this reclassification.