Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

I believe some fellow members might have come across this similar situation.

This question is for a Covid-19 kit developed by a foreign manufacturer. Are clinical validation studies outside of US acceptable and if so, what is the requirement for lab qualification? 
If the Manufacturer doesn't have all the organisms to be tested as part of the cross-reactivity, what should be done in such scenarios.

I sincerely appreciate any feedback.

Thanks in advance!

Possibly. I suggest you go here: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19 Scroll down all the way to IVDs and work from there. There's a specific FDA e-mail listed in there for diagnostics. It also tells you requirements, etc.

Good luck,

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Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
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Original Message:
Sent: 10-Apr-2020 09:39
From: Anonymous Member
Subject: EUA for Covid-19 Kit ( molecular assay) for foreign manufacturer

This message was posted by a user wishing to remain anonymous

Hello all,

I believe some fellow members might have come across this similar situation.

This question is for a Covid-19 kit developed by a foreign manufacturer. Are clinical validation studies outside of US acceptable and if so, what is the requirement for lab qualification?
If the Manufacturer doesn't have all the organisms to be tested as part of the cross-reactivity, what should be done in such scenarios.

I sincerely appreciate any feedback.

Thanks in advance!