FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
FDA
The new article provides additional clarifications regarding various testing methodologies to be used when assessing the thermal effect caused by medical devices when used for the intended purpose, as well as the risks associated with it.
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 new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
FDA
The new article describes potential questions to be discussed with the authority in the context of the Q-Submission Program interactions.
