FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.
FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Heal...
Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the safety labeling of intrau...
Federal Register notice: FDA makes available a replacement final guidance entitled Investigational Covid-19 Convalescent Plasma.
Federal Register notice: FDA withdraws a May-issued final guidance entitled Investigational COVID19 Convalescent Plasma because the agency is issuing ...
Former FDA commissioner Scott Gottlieb criticizes a recent move by HHS to redirect its authority to prevent FDA and other health agencies from introdu...
FDA approves a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications.
Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as Class 1 for three events and Class 2 for the ...