Este artículo es publicado originalmente en:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm427692.htm

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance

FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF

This guidance document is for comment purposes only.

Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions on the content of this guidance, contact CBER, Office of Communication, Outreach, and Development (OCOD) at 240-402-7800 or 800-835-4709.  For questions about this document concerning products regulated by CDRH , contact the Office of the Center Director at 301-796-5900.  If you need additional assistance with regulation of combination products, contact the Office of Combination Products at 301-796-8930.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Office of Combination Products in the Office of the Commissioner (OCP)
December 2014

The Fat SVF/Minimal Manipulation FDA Guidance is Out...

Chris CentenoCEO at RegenexxContribuidor principal

From reading this, if I were processing fat in the U.S. to obtain SVF, I would be very concerned...

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm427692.htm

"Example 10-1: Original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement."

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft... fda.gov

This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit...