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.
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.
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