This article applies to:
This item introduced in E-Prime 1.x (126.96.36.1999).
The E-Prime End User License Agreement (EULA) includes an authorized use restriction that limits the use of E-Prime to research purposes only. E-Prime is not authorized for medical use.
The following text is part of the E-Prime End User License Agreement (EULA) and it defines the authorized use that is granted to the end user for the E-Prime software package. The EULA is displayed as part of the E-Prime installation procedure and must be agreed to in order to complete the installation. The EULA is also displayed when the "About E-Studio..." menu option is selected from the Help menu in E-Studio. The EULA from E-Prime 2.0 SP1 (version 188.8.131.523) reads as follows:
Unless otherwise granted and stated in writing by an authorized entity or notifying body, your right to use these products is strictly limited to research purposes; you may not use them for medical treatment or diagnosis. These products have not yet been reviewed, certified, or approved by the FDA or similar organization for use with patients or clinical purposes. These products are not to be used, in whole or as part of, any life-supporting or life-sustaining device or system, nor for any use in which a failure of the SOFTWARE PRODUCT could result in harm or injury to another individual. You are solely responsible for the proper and safe conduct of your research studies. All use of these products must be in compliance with 45 CFR 46 and appropriate human subjects' procedures as they exist within your institution. By accepting the terms of this EULA you acknowledge your understanding of, and compliance with, these stated restrictions.
Disclaimer: The purpose of this explanation is strictly to clarify the meaning and intent behind the EULA. The explanation found here does not replace the binding legal agreement found in the EULA. Please note that the entire E-Prime EULA, including the Authorized Use section, is likely to change with each version of E-Prime.
The Authorized Use statement says that E-Prime is strictly intended for research purposes. This is intended to emphasize the point that E-Prime, as well as the tasks that you author in E-Prime, cannot be used directly for clinical diagnosis of patients or clinical assessment of any kind. Any use of E-Prime outside of research (or academic/educational) use has the potential to result in harm or injury to another individual and may be in violation of FDA and/or European MDD regulations. This is a particular concern and elevated level risk when E-Prime is used to interface with other 3rd party hardware/software components (even if those components carry their own regulatory approval), and/or where the results obtained from such a system would directly impact clinical decision making or patient treatment paths.
These restrictions are in place because E-Prime has not been approved by the FDA or any similar organization for medical use. Even if that type of approval was obtained, it would not inherently apply to the tasks that you author using the system; any task or group of tasks created with E-Prime could be considered a medical device in and of themselves, dependent on the system's intended use.
Using E-Prime outside of a research or education environment is considered a violation of the End User License Agreement. By agreeing to the EULA, you state that you agree with these terms and understand that using E-Prime for direct clinical assessment or medical purposes is beyond the scope of its intended use. The end user and/or experiment author has the burden of conducting the requisite design control, risk analysis, verification testing and validation testing that is appropriate for the intended use of E-Prime and the tasks you create. The end user further assumes the burden of obtaining approval from any of the appropriate regulatory agencies prior to utilizing E-Prime in whole, or in part, with such a system.