Zdrowie i gospodarka · 8.05.2007
General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for the proposed rule, published in the Federal Register of October 31, 2006 (71 FR 63278). The proposed rule would reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is taking this action in response to two requests for an extension of the comment period for this rulemaking. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.