Federal Register notice: FDA proposes to amend the biologics regulations by removing the specified test for the presence of mycoplasma for live virus ...
Federal Register notice: FDA issues a final rule amending general biologics regulations relating to time of inspection requirements and to remove duti...
FDA clears an Intellirod Spine de novo submission for its disposable spinal rod strain sensor, the LoadPro.
Fresenius Medical Care agrees to pay $231 million to resolve investigations by the Department of Justice and the Securities and Exchange Commission in...
Federal Register notice: FDA issues a final rule to classify in vitro diagnostic devices for Bacillus species detection into Class 2 (special controls...
Federal Register notice: FDA issues a final rule to classify posterior cervical screw systems into Class 2 (special controls) and to continue to requi...
Federal Register notice: FDA amends the medical device reports of corrections and removals regulation to correct three inaccurate cross-references.
Legislation introduced by Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) seeks to make permanent a new FDA policy that was put in place in December to...