FDA classifies as Class 1 a King Systems recall of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image.
FDA says it has received reports of spot shortages of some medical devices due to the global coronavirus outbreak.
FDA cautions against using unapproved products that claim to clean CPAP machines and accessories with ozone gas or UV light.
A New York federal judge rules that 10 years of clinical trial information that HHS said did not have to be filed at ClinicalTrials.gov really is requ...
FDA approves an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and vomiting (PONV) in ...
HHS deputy inspector general Suzanne Murrin tells House Appropriations Committee members there are steps FDA can take to reduce medical device risks a...
Two Hyman, Phelps attorneys see a troubling pattern in deadlines being missed by CDRH.
FDA commissioner Stephen Hahn says media reports are wrong about the agency monitoring 150 prescription drugs that could be in short supply if plants ...