The Food and Drug Administration yesterday revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing. As recommended in August, the revised EUAs and labeling call for users with COVID-19 symptoms to repeat testing at least twice over three days and users without symptoms to repeat testing at least three times over five days, with at least 48 hours between tests.

In other news, the FDA yesterday designated the recall of 60,500 filters used in breathing systems a Class I recall, meaning the devices may cause serious injury or death. Teleflex recalled the Iso-Gard S filters in August. On Monday, FDA also alerted health care providers to a shortage of tracheostomy tubes, used to help people breathe after a tracheotomy, including a tube made by ICU Medical for pediatric patients. The agency recommends providers and other caregivers consider using certain conservation strategies.
 
 

Related News Articles

Headline
Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired…
Headline
In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an…
Headline
The Government Accountability Office Dec. 21 recommended the Food and Drug Administration and Cybersecurity and Infrastructure and Security Agency update a 5-…
Headline
A CDC study  released Dec. 21 found low COVID-19 and flu vaccination coverage for most adults, and low RSV vaccination coverage for adults aged 60 and…
Headline
The Home Test to Treat program now offers free testing, telehealth and treatment for both COVID-19 and flu to eligible adults nationwide, the National…
Headline
The Food and Drug Administration on Nov. 16 announced a new report from government contractor MITRE, Next Steps Toward Managing Legacy Medical Device…