FDA Reopens Comment Period for Hemostatic Device Draft Guidance

The FDA is reopening the comment period on a draft guidance and proposed rule pertaining to absorbable hemostatic devices. The rule and the guidance, “Class II Special Controls Guidance Document: Absorbable Hemostatic Device,” were originally released for comment in October 2006. The FDA says it received a petition last year under 21 CFR 10.30 and 10.35 requesting that it not issue a final rule and the draft guidance until an updated administrative record was made public. The petition also asked the agency to reopen the rulemaking process on this issue. Comments on both the guidance and rule are due by Oct. 14.