FDA Finalizes Guidance on De Novo Classifications, Touts Procedure’s Use as Pathway to Market for Devices
November 1, 2017 at 04:52 PM EST
The FDA Oct. 30 finalized its guidance on the de novo classification process for medical devices, providing “updated recommendations” for interactions with agency staff as well as recommendations about the information that device sponsors should submit to the FDA when seeking a path to market via the de novo classification process.
For years, the FDA has worked to highlight t... Read More
