A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis

@inproceedings{Doros2016AMF,
  title={A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis},
  author={Gheorghe D Doros and Philip Lavin and Michael J Daley and Larry E. Miller},
  booktitle={Medical devices},
  year={2016}
}
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. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon… CONTINUE READING
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for Healthcare Informatics [webpage on the Internet

  • IMS Institut
  • Medicines Use and Spending Shifts: A Review of…
  • 2015

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