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Zdrowie i gospodarka · 11/09/2008

General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register of October 31, 2006 (71 FR 63728) to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). FDA is reopening the comment period to update comments and to receive any new information. 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in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

Source: Federal Register — Food and Drug AdministrationOpen original release →