Department of Health and Human Services September 11, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a draft guidance entitled ``Class II Special Controls Guidance Document: Absorbable Hemostatic Device.'' The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirements of special controls if it is reclassified. 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 reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls).

The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Devices Good Manufacturing Practice Advisory Committee (DGMPAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.