FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for ...
Attorney Jeffrey Shapiro says the FDA final regulation on intended use is a modest improvement over past practice.
FDA recommends hospitals standardize their use of purple medical device bracelets or wristbands to only signify Do Not Resuscitate status.
Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with da...
A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and StemMaxx are unapprove...
FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.
FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.
MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements on manufacturers.