# 1.3 Considerations [![hackmd-github-sync-badge](https://hackmd.io/wieobQ2UTFqTCrrvNrBd-g/badge)](https://hackmd.io/wieobQ2UTFqTCrrvNrBd-g) - It is understood that the stringent policies for design and development of conventional ventilators cannot be met in a short period of time, thus, several considerations for the device’s safe development and usability are considered under the interim order and are relevant only in the context of design and development for emergency situations such as COVID-19 global pandemic. - The requirements of this document are meant for trained operator use only and thus lay operator requirements are not considered. - The documentation and submission protocols across various organizations vary. It is recommended that the user consider them carefully before applying.