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

MRA Update: CABs Will Beat Extended Transition Deadline

This article was originally published in The Gray Sheet

Executive Summary

The first conformity assessment bodies (CABs) will be listed under the U.S./EU mutual recognition agreement by the winter of 2003, Commerce department officials predict

You may also be interested in...



MRA Set For Baseline Activation: Niedelman Contrasts ISO, QSIT Approaches

A delegation representing U.S. interests in the U.S./EU mutual recognition agreement is meeting with the European Commission in Brussels to discuss progress on U.S. conformity assessment bodies (CABs)

MRA Set For Baseline Activation: Niedelman Contrasts ISO, QSIT Approaches

A delegation representing U.S. interests in the U.S./EU mutual recognition agreement is meeting with the European Commission in Brussels to discuss progress on U.S. conformity assessment bodies (CABs)

RAPS In Brief

PMA ABCs: Action definitions and procedures guidance will explain terms related to all PMA decisions listed under the performance goals of MDUFMA, ranging from "approval" and "approvable pending GMP" to "denial" and "abandonment," CDRH Premarket Approval Section Director Thinh Nguyen reports at the Regulatory Affairs Professionals Society medical device conference in San Francisco March 4. One of six PMA-related guidances under development, the document will provide criteria for decision letters and explain how certain actions affect FDA's review clock and performance goals...

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT016838

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