[PDF Printable Version - 141 KB]1
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091730.pdf
FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(3) without initially seeking prior comment because the agency has determined that prior public participation is not feasible or appropriate because of the timeframes established by section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.
FDA invites comments on this guidance. Submit written comments at anytime to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov 2. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. FDA will review any comments we receive and revise the guidance when appropriate.
Additional copies of this guidance are available from the Office of Communication, Outreach and Development (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm 3.
For questions on the content of this guidance, contact the Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
February 2007
Updated March 2011
----------------
full-text (large):
Tissue Guidances > Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
No hay comentarios:
Publicar un comentario