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...

1. EUA Template for At-Home COVID-19 Sample Collection Kits
By: Madison Wheeler
The FDA has recently released a new emergency use authorization (EUA) template aimed
atdevelopers of at-homesamplecollectionkitsfor COVID-19tests.EUA’sarethe 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
templatethenmovesinto the proposed intended usesection, which is partially completed andhas
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 info@emmainternational.com to get started.
1 FDA(May 2020) FDAtakes steps tostreamlinedevelopmentoftests withat-homesamplecollection retrievedon 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
2 FDA(May 2020) Policy for Coronavirus Disease-2019 Tests during thePublic Health Emergency (Revised) retrieved on06/10/2020from:
https://www.fda.gov/media/135659/download