CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the Division of Ophthalmi...
FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical products.
FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.
FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...
FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.
The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gutting the 40-year-old...
Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...
