The Sunlight Regulatory Device License

Robert L. Read

Pierre Lonchampt, Darío Hereñú

https://github.com/PubInv/RegulatorySunlight

The Need for a New License

This is an attempt to construct a free-libre, open-source license aimed specifically at medical devices. The COVID-19 pandemic demonstrated the need for open, transparent devices which are both supply-chain resilient and fully tested under normal regulatory regimes. The Sunlight Regulatory Device License aims to support an ecosystem of for-profit and non-profit firms that create medical devices, thus alleviating the lack of these devices now and in the future. The Sunlight Regulatory team believes that this ecosystem requires a license that encourages reuse of device designs and test documentation by forcing publication for regulatory clearance at the time of reuse.

We are currently using a Google doc as our working document.

License Use Scenario

A Fictitious Use-Case that Shows the Sunlight License in Practice

The development and licensure of a new medical device would begin as usual. For example, Public Invention could build a VentMon as a tester with no approval. If it decides to use this to monitor live human patients, it would then develop an approval application and release it under the RDAA.

However, under the Sunlight Regulatory Device License, if a competitor decides to make a better VentMon to sell and manufacture, they have the right to read and review the VentMon RDAA materials. If they apply for regulatory approval using any of these materials, they must fully release their own application and all related materials under the RDAA.  This is the price they pay for using the Public Invention material.

Over time, this process would develop a body of shared, reusable and improvable material about Ventilation Monitoring device design. Manufacturing would become available to both the public and other companies. Ten years from later, the wider community would have better ventilation monitoring at lower prices than before. This is the goal of the Sunlight Regulatory Device License team.

Related Open-Source Projects

If interested in learning more about our other projects, check the following pages for updates and volunteer opportunities:

• Ventilator Verification Project
• The Euler Notebook

The Sunlight Regulatory Device License team is looking for new team members with the following backgrounds:

• Lawyers or paralegals who work with copyright licensing for open-source medical device designs

If interested in joining the project, please reach out to Robert L. Read, Volunteer Coordinator Miriam Castillo, or Volunteer Now.

The team’s goals include:

• Recruiting an additional lawyer to assist, and
• Recruiting a regulatory expert to vet the “covered matter”

Based on some work by Sabrina Merlo of OSMS, Robert Read wrote this essay proposing a new kind of FDA clearance. This is independent of the license, but it is related as a motivational work. It was submitted to the Day One Project.