Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Completes Human Dura Mater Classification, Undeterred By CJD Threat

This article was originally published in The Gray Sheet

Executive Summary

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

You may also be interested in...



Tissue Registration & Listing Reg Draws Attention To Unissued FDA Rules

FDA is implementing new tissue bank registration and listing requirements, though the two remaining parts of the tripartite tissue regulatory framework have yet to be finalized

Tissue Registration & Listing Reg Draws Attention To Unissued FDA Rules

FDA is implementing new tissue bank registration and listing requirements, though the two remaining parts of the tripartite tissue regulatory framework have yet to be finalized

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

Latest Headlines
See All
UsernamePublicRestriction

Register

MT019504

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel