2004N-0234 - Annual Guidance Agenda
FDA Comment Number : EC3
Submitter : Ms. Dawn Moore Date & Time: 09/23/2004 06:09:50
Organization : Covalent Medical, Inc.
Device Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
We believe the following new guidance document should be added to the 2004 Annual Guidance Agenda; "Class II Special Controls Guidance Document: Absorbable Hemostatic Agent, Surgical Device; Draft Guidance for Industry and FDA". The Agency has proposed that this device be downclassed to Class II. On 24 July 2003, the General and Plastic Surgery Devices Panel voted unanimously to reclassify the absorbable hemostatic agent devices into Class II for those devices without bovine thrombin. The Agency has a long history with these devices as such products were used in the early 1940's. The device specifications, performance characteristics and associated risks are well understood. Since 1976, CDRH has approved ten absorbable hemostatic agents.