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GUIDANCE DOCUMENT

Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container Guidance for Industry March 2011

Final
Docket Number:
2007D–0025;FDA–2011–N–0148]
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This document was developed as a special control to support the classification of a cord blood processing system and storage container into class II (special controls). This guidance is relevant to devices intended for use in the processing and the storage of cord blood.


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: 2007D–0025;FDA–2011–N–0148].

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