As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving back” to the communities that desperately need the help.
This two-part series will highlight these projects and the extraordinary people behind them.
Part I: The Humn Project
During our recent R&Q DEVICE L❤️VE Live!, our subject matter experts discussed the use of the U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) process and E.U.’s Medical Device Regulation (MDR) Article 59 to release medical devices needed for the COVID-19 Public Health Emergency. Check out the on-demand recording of this show here.
The U.S.’s EUA allows medical devices that are uncleared or unapproved by the FDA to be used during a national health emergency, in this instance to help prevent the spread of COVID-19. The EUA process is enabled by a Declaration of a Public Health Emergency by the U.S. Department of Health & Human Services (HHS). This process allows for manufacturers of necessary medical devices, in vitro diagnostic devices (IVD), and pharmaceuticals to request an expedited and interactive EUA review to address unmet needs during a health emergency, as we have seen at the global scale during the current COVID-19 pandemic.
This is where Daniel Clark, President of Linear Health Sciences, an Oklahoma-based medical device company and a longtime client of ours, comes in. Typically specializing in the development of products for various types of medical tubing based on proprietary, breakaway safety-valve technology, Clark partnered with his twin brother and younger sister to found the benefit organization, The Humn Project, to develop a UV-C disinfectant light to combat the spread of the devastating virus with a focus on human safety while using the device.
“Thanks to the incredible work R&Q has led, we're in a great position currently looking forward to making a fundamental impact on the war against this invisible enemy.” – Daniel Clark, The Humn Project
When R&Q heard that Clark and his team were working to bring an open-source, not-for-profit medical device to help prevent the spread of COVID-19 through the EUA, we knew we had to use our team’s expertise to help their efforts at no expense. To assist the project, our team developed a Regulatory Strategy for the device's EUA submission to support labeling and testing plans by compiling and drafting the pre-EUA submission, serving as Regulatory Correspondent with the FDA, and planning to compile the EUA submission in the near future.
We are proud to support remarkable organizations like Humn Project because it is in R&Q’s blood to want to improve the lives of others and we love to back people making a difference in our communities. As Andrea Clark, Marketing and Commercial Partner of Humn Inc., stated:
“Humn Project was built out of this need to strengthen public health by building essential products to benefit society at-large. With no other competing interests, Humn Project recognizes inherent disparities within public health and we are working to even the playing field. Currently, this work includes a novel FAR-UVC disinfectant lamp that reduces the spread of germicidal spores. Working with multiple partners, from engineers and testing experts to the R&Q Regulatory experts, we are expediting our MCM through EUA to get this into clinical essential workers’ facilities as quickly as possible."
By providing pro bono regulatory support with the EUA process to obtain FDA authorization for Humn Project, R&Q hopes to support its incredible mission and get the device to market quickly and safely. Brian Clark, Humn’s Managing Partner, reiterates the urgency of getting this technology into the hands of those that need it:
"Our mission at Humn is to create open-source technology-driven solutions that positively impact communities with efficient scale. We are a benefit organization, and our first opportunity is to commercialize the promising research on the use of Far-UVC as a germicidal disinfectant.
Unlike traditional germicidal UV lamps, research indicates this form of UV light can destroy viruses and bacteria, yet still operate safely around humans. The Far-UVC product that we're bringing to market provides direct support for our communities and front-line workers, and benefit the broader health outcomes of our communities."
Want to learn more about this topic? Join us on Tuesday, May 26 for R&Q’s May Webinar on the FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for the prevention and treatment of COVID-19. In this free webinar, we will discuss both emergency application processes, provide answers to the many questions we have received, and share tips and lessons learned from our experiences. Click the button below to learn more and register:
If you are looking for help with EUA or other regulatory needs, check out our Regulatory Services page here and contact us today! Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know.
Source: FDA Emergency Situations Medical Devices. Accessed 11 May 2020. https://www.fda.gov/medical-devices/medical-device-safety/emergency-situations-medical-devices.
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R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
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