Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period

概要

The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for a draft guidance entitled "Class II Special Controls Guidance Document: Absorbable Hemostatic Device." FDA published a notice of availability of the draft guidance in the Federal Register of October 31, 2006 (71 FR 63774). The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices, if the device is reclassified. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls)