![FDA Draft Guidance on Tissue Heating/Cooling Devices: Overview](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-tissue-heating-cooling-devices-overview.jpg)
May 30, 2024
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.
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![FDA Guidance on Tissue Heating/Cooling Devices: Testing Methodology](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-tissue-heating-cooling-devices-testing-methodology.jpg)
May 22, 2024
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.
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![FDA Guidance on Tissue Heating/Cooling Devices: Specific Aspects](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-tissue-heating-cooling-devices-specific-aspects.jpg)
May 22, 2024
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.
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![FDA Guidance on De Novo Classification Process: Overview](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-De-Novo-overview.jpg)
May 20, 2024
FDA
The article provides a general overview of the regulatory framework for innovative medical devices intended to be marketed and used in the US.
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![FDA eSTAR Updates: Overview](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-eSTAR-overview.jpg)
May 20, 2024
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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![FDA Guidance on De Novo Classification Process: Basics](https://www.regdesk.co/wp-content/uploads/2024/04/FDA-on-De-Novo-basics.jpg)
May 20, 2024
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.
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