Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing

Tissue Antigens. 2014 Mar;83(3):193-4. doi: 10.1111/tan.12275. Epub 2014 Jan 7.

Authors

F Naso¹, L Iop, M Spina, G Gerosa

Affiliation

¹ Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padova, Padova, Italy.

PMID: 24397352
DOI: 10.1111/tan.12275

No abstract available

Keywords: alphaGal; biomaterials; food and drug administration; xenoantigen.

Publication types

Letter

MeSH terms

Animals
Commerce*
Device Approval / legislation & jurisprudence
Europe
Humans
Legislation as Topic*
Prostheses and Implants
Tissue Engineering / economics*
Tissue Engineering / instrumentation
Tissue Engineering / legislation & jurisprudence*
Transplantation, Heterologous / economics*
Transplantation, Heterologous / legislation & jurisprudence*
United States
United States Food and Drug Administration*