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Posted On: 04/28/2020 11:57:24 PM
Post# of 11802
Thank you and thank you Tim and Sara and everyone at the FDA for your hard work. Much appreciated. Well, I've got a question about whether a pathway will be created for home tests. I know that you are very interested in approving home tests as well as taking samples at home by individuals. But it appears that there is not a specific pathway for home tests -- just point of care.
That'sagreatquestion.We'restrivingtogettheserologytemplatesoutas soon as possible. Maybe even today. That would be awesome. We are working on templates that could be used for home collection and home testing but they are not near ready yet to share.
In the interim, we asked developers to send us their inquiries at CDRH-EUA- templates@fda.hhs.gov. As appropriate we're happy to jump on a call and talk through the issues that we see and collaboratively work on a steady design to
our feet.
FDA Moderator: Irene Aihie 04-22-20/12:15 pm ET Page 11
(Douglas Ross): TimothyStenzel:
FDA Moderator: Irene Aihie 04-22-20/12:15 pm ET Page 12
show that testing is accurate. Hopefully, that addresses your q
That'sagreatquestion.We'restrivingtogettheserologytemplatesoutas soon as possible. Maybe even today. That would be awesome. We are working on templates that could be used for home collection and home testing but they are not near ready yet to share.
In the interim, we asked developers to send us their inquiries at CDRH-EUA- templates@fda.hhs.gov. As appropriate we're happy to jump on a call and talk through the issues that we see and collaboratively work on a steady design to
our feet.
FDA Moderator: Irene Aihie 04-22-20/12:15 pm ET Page 11
(Douglas Ross): TimothyStenzel:
FDA Moderator: Irene Aihie 04-22-20/12:15 pm ET Page 12
show that testing is accurate. Hopefully, that addresses your q
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