Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Absorbable Hemostatic Device." The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). This draft guidance is not final, nor is it being implemented at this time.