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

MDR Revision Is More Restrictive, Misses Opportunities – NEMA, AdvaMed

This article was originally published in The Gray Sheet

Executive Summary

FDA should withdraw its medical device reporting direct final rule and "proceed with the usual procedures for notice and comment on the companion proposed rule," NEMA asserts in a May 12 FDL-1letter to the agency

You may also be interested in...



FDA MDR rule speaks plainly

Direct final rule to translate FDA's medical device reporting rule into plain language will become effective July 13, FDA confirms. The agency received 16 comments, including letters from NEMA and AdvaMed, urging it to make revisions to the MDR reg before moving forward with the final rule (1"The Gray Sheet" May 30, 2005, p. 6). However, FDA has decided to implement the plain language modifications as initially proposed in February. FDA "did not receive any significant comment on the plain language revisions," FDA explains in the Federal Register notice...

FDA MDR rule speaks plainly

Direct final rule to translate FDA's medical device reporting rule into plain language will become effective July 13, FDA confirms. The agency received 16 comments, including letters from NEMA and AdvaMed, urging it to make revisions to the MDR reg before moving forward with the final rule (1"The Gray Sheet" May 30, 2005, p. 6). However, FDA has decided to implement the plain language modifications as initially proposed in February. FDA "did not receive any significant comment on the plain language revisions," FDA explains in the Federal Register notice...

Second MedWatch Form Revision In Two Years Is Burdensome – AdvaMed

FDA should grant a six-month grace period for firms to come into compliance with changes to the MedWatch adverse event reporting form, according to AdvaMed

Latest Headlines
See All
UsernamePublicRestriction

Register

MT022181

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