The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home sample collection kits for COVID-19 tests. EUA’s are the FDA’s provision which allows the use of unapproved medical products when there are no other adequate or available alternatives. This newly released template lays out the FDA’s current thinking on what data and information developers should submit in order to facilitate and streamline the EUA process.
The template is aimed at home sample collection for molecular diagnostic testing which is developed by either laboratories or commercial manufacturers. Additionally, this template only applies to prescription use home collection devices that utilize anterior nasal swab or saliva specimens. Any developers who are considering other types of specimens (i.e. tongue swabs or stool samples) are instructed to contact the FDA directly to discuss validation strategy.1
The template information itself walks the developer through all the information necessary to submit the EUA. It covers administrative information such as purpose for submission, applicant information, and even has a pre-filled approval/clearance status disclaimer. The template then moves into the proposed intended use section, which is partially completed and has easy-to-understand fillable sections. The information the developer is responsible for completing includes what type of specimen the device collects, the mechanism via which the individual is determined to be appropriate for COVID-19 testing, and the name of the laboratories that will be testing the samples. Other sections of the template walk developers through:
- Device Description (including specimen collection control and processing)
- Product Manufacturing
- Performance Evaluation
- Instructions for Use
- Record Keeping and Reporting Information to the FDA2
The FDA has been developing EUA templates as part of an interactive review for Pre-EUA/EUA submissions and will likely continue to update them to facilitate the application process for developers. If you are developing a home sample collection kit for COVID-19 and need help applying for an EUA, EMMA International has the expertise to help! Give us a call at 248-987-4497 or email firstname.lastname@example.org to get started.
1FDA (May 2020) FDA takes steps to streamline development of tests with at-home sample collection retrieved on 06/10/2020 from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-steps-streamline-development-tests-home-sample-collection
2FDA (May 2020) Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised) retrieved on 06/10/2020 from: https://www.fda.gov/media/135659/download