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 recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
FDA
The article provides an overview of the existing legal framework and also describes the key concepts related to the matter.
FDA
The new article describes in detail the approach to be followed when evaluating medical devices impacting, intentionally or unintentionally, the temperature of human tissues.
FDA
The article provides a general overview of the existing legal framework, highlighting the key points to be considered by the parties interested in placing their products on the US market.
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.
