US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market.
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. However, applying for a COVID-19 EUA Letter from FDA is not as easy as might be expected, despite the overwhelming need for diagnostic tests to address the SARS-CoV-2 pandemic. Not surprisingly, there are still no authorized rapid antibody tests at this time, creating an opportunity for distributors and agents to import these tests.
Despite a less rigorous regulatory pathway and the ability to market your product prior to receiving full marketing approval, the EUA process itself is unfamiliar to most and has been modified more than once since initiation. In the sections below, we outline four pitfalls or submission package deficiencies that can cause delays and/or rejection of the application.
Remember, the EUA regulatory pathway is not intended as a permanent solution, but rather as a temporary process to address a critical need. Once the EUA process for a particular category expires, all EUAs will become defunct and EUA products removed from the market unless applications have been submitted via the standard (i.e., long and laborious) regulatory pathways.
ISS has assisted with the submission of dozens of EUA packages, and not just for coronavirus-specific drugs, diagnostics, and devices. We’ve worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements. We know this process inside and out.
Complete the form below to download our free white paper “Applying for an FDA Coronavirus EUA Letter” or contact us today to discuss how we can help.
We have summarized our experience securing EUA letters into this easy-to-read, practical guide.
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