Zdrowie i gospodarka · 06/04/2006

General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities

The Food and Drug Administration (FDA) is proposing to reclassify the topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls). The device is intended to surround a patient's limb and apply humidified oxygen to aid healing of chronic skin ulcers such as bedsores. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.