FDA Issues Draft Guidance on Biocompatibility Testing Under the ASCA Program
FDA has issued draft guidance on biocompatibility testing of medical devices under the ASCA Program, covering recognized standards, laboratory accreditation, test methods and premarket submission content.
FDA Publishes Updated Guidance on Pyrogen and Endotoxins Testing
FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.
FDA Updates Recognized Biocompatibility Standards – Recognition List No. 065
FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.