Hello,
Our company currently holds an EUA for VTM and is looking to combine this with a swab (I've been told the manufacturer of the swab has an EUA, although I've yet to confirm that) into a kit for the collection and transport of viral specimens for COVID-19 testing. Our EUA only covers transport of specimens. Assuming the swab manufacturer actually has an EUA for their swab, would we also be required to submit an EUA application for the kit? My gut feeling tells me that, yes, we would need to submit an EUA application for the kit because our company's EUA only covers transport, and the intended use is changing to collection and transport. I also read in the guidance document from FDA that the VTM EUA only covers transport, not collection. Does anyone have experience with this or advice to offer? Thank you!
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Ashleigh Rickey
Springboro OH
United States
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