Medical Use. You may only develop Your Software for Medical Use that is for non-commercial research purposes, within the Research Community. “Medical Use” is any use in medically classified devices or environments, for instance hospitals, surgeries, or other healthcare environments. Examples of Medical Use include systems for Assistive and Alternative Communication (AAC), medical condition assessment solutions, vision or eye condition solutions and solutions or systems intended to be used in hospitals, surgeries and doctor’s consulting rooms. If you wish to commercialise Your Software for Medical Use, or distribute it outside of the Research Community, then you must contact Tobii Pro at xxx.xxxxx@xxxxx.xxx to arrange a Medical Use License.
Medical Use. Company understands and acknowledges that the Products are not intended for any medical- or health-related uses (including, without limitation, any use for temperature measurement in humans) nor have any of the Products been cleared or approved by the U.S. Food and Drug Administration (“FDA”) or any other governmental authority. Company shall be solely responsible for (1) any use, promotion, marketing, commercialization, or sale of the Products performed by or on behalf of Company for any medical- or health-related purposes (including, without limitation, any use for temperature measurement in humans), and (2) any incorporation or bundling of any Product into or with any other product, system, kit, or package for any medical- or health-related purpose performed by or on behalf of Company (collectively, the “Health-Related Uses”). Company further acknowledges and agrees that, should Company engage in any Health-Related Uses, Company shall be solely responsible for ensuring compliance with the applicable laws and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder by FDA, for the use of any Product for the Health-Related Uses and for obtaining and maintaining any approvals, clearances, licenses, registrations, or permits required by FDA or any other governmental authority for the use of any Product for the Health-Related Uses. Company shall notify FLIR and, if applicable, provide FLIR with copies of any notices or communications of any FDA or other governmental authority investigation or other inquiry or other material governmental notice or communication relating to the Products (including any Company products that incorporate a Product) promptly after, but in no case later than one (1) day after Company becomes aware of such investigation, inquiry, notice, or communication. Company shall provide FLIR with a copy of, and opportunity to comment on, Company’s response(s) to any such investigation, inquiry, notice, or communication prior to Company’s submission of such response(s).
Medical Use. Developer understands and acknowledges that the SDK and FLIR EST Camera Products are not intended for any medical- or health-related diagnostic uses (including, without limitation, any use for body temperature measurement in humans) nor have the Products, been cleared or approved by the U.S. Food and Drug Administration (“FDA”) or any other governmental authority. Developer shall be solely responsible for any use, promotion, marketing, commercialization, or sale of the App for use with FLIR EST Camera Products for any medical- or health-related purposes. Developer shall be solely responsible for ensuring compliance with the applicable laws and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder by FDA, for the use of the App with a FLIR Device for Health-Related Uses and for obtaining and maintaining any approvals, clearances, licenses, registrations, or permits required by FDA or any other governmental authority for the use of the APP with any FLIR EST Camera Product.
Medical Use. The Program has not been approved by the US Food and Drug Administration (FDA) under the regulations governing Medical Devices.
