SILVER SPRING, MD — On March 3, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary,...
In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include...
The FDA continues to sound the warning on unauthorized SARS-CoV-2 rapid antigen tests. On March 1, the agency issued a trio of Safety Communications warning providers and consumers not to use: The Celltrion DiaTrust COVID-19 Ag Rapid Test—the one that comes in a green...
CARLSBAD, CA — ChromaCode, Inc., a company redefining molecular testing through data science, announced on Feb. 23 that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new...