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

Device Industry Has Questions About ‘MedWatch Plus’ Adverse Events System

This article was originally published in The Gray Sheet

Executive Summary

Device trade group AdvaMed is seeking clarity on how FDA's new, all-electronic MedWatch Plus safety information reporting system will relate to the current system, particularly for firms that already submit adverse event reports electronically

You may also be interested in...



CDRH Details Path Forward For National Post-Market Surveillance System

The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.

GAO “High-Risk List” Urges Enhanced FDA Oversight Of Medical Products

The Government Accountability Office added enhanced oversight of devices, drugs and other medical products to its list of "high-risk" priorities in a report to Congress released Jan. 22

GAO “High-Risk List” Urges Enhanced FDA Oversight Of Medical Products

Recent initiatives hold promise, but “effective implementation” is required to make “meaningful differences,” oversight office says.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT026942

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