<b>CAD Files Heater Cooler Regulatory Science Tool</b>

<p dir="ltr">These files are CAD files associated with the Heater Cooler RST from CDRH/OSEL which can be found here - <a href="https://cdrh-rst.fda.gov/protocols-characterizing-aerosol-emission-heater-cooler-devices" target="_blank">Protocols for Characterizing Aerosol Emission from Heater Cooler Devices | Center for Devices and Radiological Health (fda.gov)</a></p><p dir="ltr">It contains the following -</p><ul><li>A ZIP file of all of the Solidworks CAD Files</li><li>A Folder of STL file for all of the individual parts (The aerator part has one with and without a bubbler)</li><li>A PDF of the CAD Drawings for the individual parts</li></ul><h4>Tool Reference</h4><ul><li>RST Reference Number: RST24CV04.01</li><li>Date of Publication: 09/24/2023</li><li>Recommended Citation: U.S. Food and Drug Administration. (2023). <i>Protocols for Characterizing Aerosol Emission from Heater Cooler Devices</i> (RST24CV04.01). <a href="https://cdrh-rst.fda.gov/protocols-characterizing-aerosol-emission-heater-cooler-devices" target="_blank">https://cdrh-rst.fda.gov/protocols-characterizing-aerosol-emission-heater-cooler-devices</a></li></ul><p dir="ltr"><b>Disclaimer</b></p><p dir="ltr">About the Catalog of Regulatory Science Tools</p><p dir="ltr">The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer-reviewed resource for stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. These tools use the most innovative science to support medical device development and patient access to safe and effective medical devices. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as <a href="https://www.fda.gov/medical-devices/medical-device-development-tools-mddt" target="_blank">Medical Device Development Tools</a> and the FDA has not evaluated the suitability of these tools within any specific context of use. You may <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program" target="_blank">request feedback or meetings for medical device submissions</a> as part of the Q-Submission Program.</p><p dir="ltr">For more information about the Catalog of Regulatory Science Tools, email <a href="mailto:RST_CDRH@fda.hhs.gov" target="_blank">RST_CDRH@fda.hhs.gov</a>.</p><p><br></p>