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

Industry Seeks More Involvement In MDUFMA Guidance Development

This article was originally published in The Gray Sheet

Executive Summary

Device industry stakeholders are expressing a desire to collaborate more closely with FDA in developing and modifying guidance related to the Medical Device User Fee & Modernization Act

You may also be interested in...



FDA Should Allow Multiple Extensions For PMA Major Deficiencies – AdvaMed

MDUFMA performance goal review metrics outlined in agency guidance should be binding, and therefore established "through notice and comment rulemaking," AdvaMed contends

FDA Should Allow Multiple Extensions For PMA Major Deficiencies – AdvaMed

MDUFMA performance goal review metrics outlined in agency guidance should be binding, and therefore established "through notice and comment rulemaking," AdvaMed contends

Greater Modular Program Familiarity Needed To Set Performance Goals – FDA

FDA will defer issuing modular PMA performance goals until gaining more familiarity with the recently- codified process, agency officials informed attendees Dec. 3 at the MDUFMA one-year meeting in Gaithersburg, Md

Latest Headlines
See All
UsernamePublicRestriction

Register

MT019430

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