FDA
The new article outlines specific aspects associated with the evaluation of medical devices impacting the tissue temperature including, inter alia, the ones related to computational modeling as one of the assessment methods to be used.
FDA
The article provides a general overview of the regulatory framework for innovative medical devices intended to be marketed and used in the US.
FDA
The article provides a brief overview of the eSTAR program and the updates thereto recently published by the US authority.
FDA
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
FDA
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
