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

DoJ Targets Device Labeling Accuracy In $300 Million Quest Settlement

This article was originally published in The Gray Sheet

Executive Summary

A $302 million settlement between Quest Diagnostics and the Department of Justice announced April 15 suggests DoJ will go after device firms for knowingly misrepresenting product information in labeling and marketing materials, even if FDA is not actively investigating the matter

You may also be interested in...



DOJ Prosecutors Turn Attention To Manufacturing, Safety Issues

The Department of Justice is increasingly tackling issues of FDA compliance beyond the standard sales and marketing fare, pursuing cases related to device manufacturing, adverse event reporting and even product labeling, recent cases suggest

DOJ Prosecutors Turn Attention To Manufacturing, Safety Issues

The Department of Justice is increasingly tackling issues of FDA compliance beyond the standard sales and marketing fare, pursuing cases related to device manufacturing, adverse event reporting and even product labeling, recent cases suggest

Device Companies Urge Whistleblowers To Air Complaints In-House

Device companies are trying to encourage employees to report suspected fraud internally rather than going straight to government authorities - with limited success to date

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT027340

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