title: Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing.
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padova, Padova, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Naso
authors.forename: L
authors.initials: L
authors.lastname: Iop
authors.forename: M
authors.initials: M
authors.lastname: Spina
authors.forename: G
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000818:Animals; D003132:Commerce; D018795:Device Approval / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D007878:Legislation as Topic; D019736:Prostheses and Implants; D023822:Tissue Engineering / Q000191:economics* / Q000295:instrumentation / Q000331:legislation & jurisprudence*; D014183:Transplantation, Heterologous / Q000191:economics* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
keywords: alphaGal; biomaterials; food and drug administration; xenoantigen