title: ASTM lights the way for tissue engineered medical products standards: jump start for combination medical products that restore biological function of human tissues.
abstract: Everybody hopes for better health and restoration of impaired bodily function, and now that hope is illuminated by the promise of powerful biological tools that make human cells grow and replace human tissue. ASTM Committee F04 on Medical and Surgical Materials and Devices is taking the lead by defining some of those tools as standards that can be used for the development, production, testing, and regulatory approval of medical products.
authors.affiliation: U.S. Food and Drug Administration, USA.
authors.forename: G L
authors.initials: GL
authors.lastname: Picciolo
authors.forename: D L
authors.initials: DL
authors.lastname: Stocum
mesh_terms: D001187:Artificial Organs / Q000592:standards / Q000639:trends; D001688:Biological Products / Q000592:standards; D001709:Biotechnology / Q000592:standards* / Q000639:trends; D046508:Culture Techniques / Q000592:standards* / Q000639:trends; D005544:Forecasting; D006801:Humans; D017410:Practice Guidelines as Topic; D012038:Regeneration; D012958:Societies, Scientific; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products