Life Sciences

FDA reopens comment period for hemostatic devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 22, 2008

For the second time, the FDA is reopening the comment period on its proposed guidance concerning reclassification of absorbable hemostatic devices. The public has until October 14 to comment.

The agency released the draft guidance “Class II Special Controls Guidance Document: Absorbable Hemostatic Device” for comment in October 2006, according to the Federal Register. The FDA had previously reopened the comment period in May 2007.

The FDA received a petition last year requesting it not issue a final rule and the draft guidance until it made public an updated administrative record. The petition also asked the agency to reopen the rulemaking process.


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