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

Manufacturer omission of MDR user facility data is common deficiency, FDA says.

This article was originally published in The Gray Sheet

Executive Summary

MANUFACTURER MDR REPORTS OMITTING USER FACILITY DATA is a common deficiency in medical device adverse event reports submitted to FDA, according to agency staffers. Many device companies are neglecting to complete Section F of the 3500A MDR form when it is left blank by user facilities or distributors, FDA says.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT007010

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