FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controller device that adjust...
Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterili...
FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.
FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.
Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erectile dysfunction Phase...
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH...
FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the Medical Device Deve...
FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.