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The agency released the draft guidance “Class II Special Controls Guidance Document: Absorbable Hemostatic Device” for comment in October 2006, according to the Federal Register.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The FDA received a petition last year requesting it not issue a final rule and the draft guidance until it made public an updated administrative record.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.
Comments
0 comments on “FDA reopens comment period for hemostatic devices ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Complete Guide to Lab Safety, 3rd Ed.
The third edition of this popular resource makes training and compliance easier by consolidating regulations from all...
-
Big Pharma Performance Before, During and Beyond the Global Recession
This report assesses the performance of the leading 15 pharmaceutical companies up to, during and beyond the recent global...
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- What does case-mix index mean to you?
- QA:Coding multiple initial infusions
- Capturing all necessary codes for IUD insertion and removal can be challenging
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- OB services: Coding inside and outside of the package
- HIPAA Q&A: Level of encryption needed for email
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Hospitalist-surgeon comanagement has no effect on outcomes
- HIPAA Q&A: Level of encryption needed for email
- Case Management Monthly, June 2012
- Searched