Former CDRH cybersecurity acting director Kevin Fu says the best companies are already submitting software bills of materials with their 510(k) and PM...
A recent inspection at Hikma Injectables USA results in a three-item Form FDA-483.
FDA publishes a draft guidance on proposed updates to an earlier breakthrough devices program guidance.
FDA closes its post-approval study requirements for Abiomed PMAs for its Impella heart pumps after reviewing favorable performance data.
FDA launches its Advancing Real-World Evidence Program intended to improve the quality and acceptability of real-world evidence approaches proposed by...
Federal Register notice: FDA announces that it is continuing a meeting program to advance the use of complex adaptive, Bayesian, and other novel clini...
PTC Therapeutics says enrollment in its Phase 2 Huntingdons disease trial has been paused in the U.S. due to an FDA request for additional data.
FDA says the 8/2 Philips Respironics recall of certain BiPAP and CPAP masks is Class 1.
