Regulatory Open Forum

This message was posted by a user wishing to remain anonymous


I am currently working on at home test for COVID and am curious to know the following:
For similar devices that came into the market using EUA.
What is the like next step? i.e
When does their EUA expire?
When do they have to apply for 510K or is it DeNovo ?
Can they be used as predicates for similar device to submit if its 510K ?

Thanks.

Hi Anon

There's a draft guidance that may be helpful, on transition plans for COVID-19 related medical devices.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends/


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Anne LeBlanc
United States
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Original Message:
Sent: 21-Jun-2022 17:46
From: Anonymous Member
Subject: EUA

This message was posted by a user wishing to remain anonymous


I am currently working on at home test for COVID and am curious to know the following:
For similar devices that came into the market using EUA.
What is the like next step? i.e
When does their EUA expire?
When do they have to apply for 510K or is it DeNovo ?
Can they be used as predicates for similar device to submit if its 510K ?

Thanks.