Important Safety Information
Research-Only Purpose
The platform discussed on this site is exclusively intended for research purposes and is not cleared or approved by the FDA for clinical use. It is solely available to researchers and research institutions who are able to customize to address the specific disease state they wish to study.
Lack of FDA Review
The safety and effectiveness of our platform have not been established through the FDA's formal review process. Researchers should be aware that the platform has not undergone the regulatory scrutiny required for general medical use and may not be used outside the research environment
Risk Awareness
The potential risks associated with our platform are not fully known. Researchers and research institutions are advised to exercise caution and fully inform all involved parties about the investigational nature of the component and the uncertainty surrounding its safety and efficacy.
Informed Consent
Researchers using this platform are responsible for obtaining informed consent from participants, clearly communicating the experimental nature of the device and any potential risks associated with its use.
Monitoring and Reporting
Researchers must comply with all applicable legal requirements related to investigational use of the platform, including, but not limited to, reporting adverse events or unexpected side effects to Openwater at safety@openwater.cc This information is crucial for ongoing evaluation and refinement of these components.
Restricted Use
This platform should be confined to research settings and not used in clinical practice or commercial applications. Their use should be limited to researchers and research institutions with the expertise to manage and monitor the investigational nature of the component. For inquiries or additional information, please contact safety@openwater.cc