MedTech Dive November 10, 2023
Nick Paul Taylor

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...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
FDA issues flu vaccine recommendations: 5 respiratory updates
5 Digital Health Areas To Be Impacted By The FDA Layoffs
FDA Approves First Biosimilar to Omalizumab
Trump's Nominees to Run FDA, NIH Get Greenlighted by Senate Committee
FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns

Share This Article