OCS Liver System Moves One Step Closer To Approval After Panel Recommendation
A panel of medical experts recommended that the US Food and Drug Administration grant premarket approval to a system designed to preserve and monitor livers destined for transplant recipients.
You may also be interested in...
As experts convene to discuss whether to recommend approval of the device, agency reviewers are concerned about what the primary endpoint and organ selection criteria used in trials mean for safety and efficacy.
Fees for filing a premarket application with the US FDA increased 2.5% for fiscal year 2022, which is significantly less than the 7% they went up last year.
Research from the University of California, San Francisco claims that many deaths involving medical devices are incorrectly reported to the US agency, and says improving the accuracy of how these deaths are classified could improve patient safety.