ARTICLE SUMMARY:
CDRH’s Timothy Stenzel suggests an expedited path to authorization for home-use COVID-19 tests. Excerpted from Pathways’ Picks, March 10.
FDA’s top diagnostics official suggests companies developing new COVID-19 tests can skip point-of-care clinic-based studies and go right to home-use studies to win both indications. “If you go straight to the home study and don’t do point of care studies, if 
we are able to authorize based on the home studies, you automatically get the point of care authorization as well,” said Timothy Stenzel, CDRH’s diagnostics office chief, during his March 10 weekly town hall call. “That is probably going to be your more efficient pathway if you have confidence in your test to be able to perform in the home.”
Stenzel has made it clear that EUA submissions for COVID-19 assays seeking home testing indications, whether prescription or over the counter, are being prioritized by reviewers over other tests. FDA authorized its first molecular home-based, over-the-counter SARS-CoV-2 test, from Cue Health Inc., on March 5. One other molecular test and three antigen tests have been authorized for at-home use. In addition to the suggestions to skip point-of-care clinic studies, Stenzel also raised the idea March 10 of performing home clinical studies with needed usability and user comprehension studies all together on the same participants. But, he emphasized, it was a “suggestion, not necessarily a recommendation because there is some risk to this.” For a prescription at-home indication, FDA requires adequate performance on 30 symptomatic patients and, for an OTC indication, a minimum of 10 asymptomatic positive cases are needed, and more post-authorization.
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