Federal Register notice: Based on a de novo request, FDA classifies Timpels Enlight 1810 ventilatory electrical impedance tomograph into Class 2.
Bipartisan legislation is introduced in the House to permanently repeal the medical device excise tax.
FDA clears an Elucent Medical 510(k) for the EnVisio Surgical Navigation System to identify the location of the tissue to be removed.
Takara Bio files a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade.
FDA clears an Ortho Clinical Diagnostics 510(k) for the Vitros XT MicroSlides, featuring new multi-test technology that allows labs to run two tests s...
FDA orders Sprout to make Addyi labeling changes to reflect agency concerns about women drinking alcohol when taking the hypoactive sexual desire diso...
FDA extends the comment period by 30 days for its Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDAs p...
Federal Register final rule: FDA rules that certain active ingredients are not allowed to be used in OTC hand sanitizers.