MedTech Dive November 10, 2023
The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.
Dive Brief:
- The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway.
- Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance.
- The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years.
Dive Insight:
The EUA program...
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