Federal Register notice: FDA makes available a final guidance entitled Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.
Federal Register notice: FDA seeks public comment on its Clinical Data Summary Report Pilot program as part of the agencys continuous assessment of th...
Kaiser Health News gives five takeaways from its review of a previously hidden FDA alternative summary medical device database that bypassed MAUDE.
FDA says 11 Medtronic insulin pumps have potential cybersecurity risks and diabetes patients who are using them should switch to a safer pump.
EdjAnalytics develops a predictive model to support CDERs decision-making process to select manufacturing sites for inspection.
Vyaire Medical recalls its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluid...
Durect submits a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain rel...
The House/Senate Problem Solvers Caucus releases principles for supporting legislation to lower drug prices.