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Comment Period Extended on Hemostatic Device

05/08/2007

Federal Register Proposed rule: FDA is reopening until 6/7 the comment period for the proposed rule, published in the 10/31/06 Federal Register,that would reclassify the absorbable hemostatic device intended to produce hemostasis from Class 3 (premarket approval) into Class 2 (special controls). The agency is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device. To view this proposed rule, click here.

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