Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

MDR Reporting: FDA Embraces Adverse Event Summaries Under MDUFA IV, But Flouts Similar FDAAA Mandate

Executive Summary

The US agency sends mixed signals by agreeing to accept more summarized Medical Device Reports under an upcoming law, yet ignoring a similar, watered-down requirement found in a 2007 congressional act. Two top industry attorneys weigh in.

Advertisement

Related Content

User-Fee Facts: 10 Key Medtech Details From US FDA Agreements
Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program
Adverse Events Dip Slightly In 2016; MDR Summary Reporting To US FDA Ticks Up
Adverse Events Stack Up At FDA; 2016 Warning Letter Data Show Troubles With MDRs, Complaints
MDUFA IV Takes Shape: A Catalogue Of Draft Commitments
Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies

Topics

Advertisement
UsernamePublicRestriction

Register

MT104269

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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