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A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US....
Autores principales: | Doros, Gheorghe, Lavin, Philip T, Daley, Michael, Miller, Larry E |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948701/ https://www.ncbi.nlm.nih.gov/pubmed/27471412 http://dx.doi.org/10.2147/MDER.S104327 |
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