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GUIDANCE DOCUMENT

Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Guidance for Industry and FDA Staff March 2011

Final
Docket Number:
2005D-0019
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document in conjunction with a Federal Register final rule reclassifying from class III to class II the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components.  This guidance document serves as the special control to support the reclassification.
 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2005D-0019.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010