The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a ...
The FDA exempts non-medical grade wearables from regulation, focusing on AI and digital health clarity. Guidance document outlines compliance for low-risk wellness products promoting healthy ...
Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...
The newest controversy concerned a rule making from which commissioner Margaret Hamburg had to recuse herself due to a perception of possible conflict of interest—ironic, considering that she is the ...
The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...