FDA Stands Firm As Canada Follows Britain, Japan In Dura Mater Suspension
This article was originally published in The Gray Sheet
Executive Summary
Health Canada's suspension of the medical device licence for Tutogen's Tutoplast Dura represents a virtual ban on the importation and sale of all human dura mater products throughout the country
You may also be interested in...
FDA Completes Human Dura Mater Classification, Undeterred By CJD Threat
FDA will classify human dura mater as a Class II device (with special controls), despite lingering concerns raised by cases of dura mater-transmitted Creutzfeldt Jakob Disease (CJD) abroad
FDA Completes Human Dura Mater Classification, Undeterred By CJD Threat
FDA will classify human dura mater as a Class II device (with special controls), despite lingering concerns raised by cases of dura mater-transmitted Creutzfeldt Jakob Disease (CJD) abroad
FDA Reasserts Dura Mater Device Status During Interim Preceding GTPs
FDA is moving forward with rules establishing human dura mater as a Class II medical device before the agency issues guidelines transitioning the product into the purview of tissue regulation