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


Retiring Rep. Dingell’s Health Policy Legacy Included Fierce Oversight Of Device Center

This article was originally published in The Gray Sheet

Executive Summary

A powerful former Chairman of the House Energy and Commerce Committee, Dingell has not been only a major player in the health care reform fight, but also a vigorous prober of FDA, launching investigations with lasting effects on the device center. The longest-serving member of the House announced his plans to retire at the end of this congressional term.

You may also be interested in...

Tough Investigator And Universal-Coverage Proponent Rep. John Dingell Dead At 92

Former House Energy and Commerce Committee Chairman John Dingell Jr., D-Mich., who was a fierce investigator of federal agencies including US FDA and sponsor of the Affordable Care Act and other legislation impacting the device industry, died at age 92 Thursday at his home in Dearborn, Mich.

CDRH Employee Surveillance Went Too Far, OIG, Lawmakers Say

FDA may have had legitimate concerns that confidential commercial information on a GE Healthcare 510(k) submission were released in 2010 by CDRH scientists, but the agency’s computer monitoring strategy lacked sufficient controls, and may have gone beyond legal bounds, suggests the HHS Office of Inspector General. The agency issued a new interim monitoring policy last September that addresses OIG’s recommendations.

FDA Listens To Industry Feedback On 510(k) Modifications Guidance Revisions

In a report to Congress, FDA stuck with device industry recommendations to merely revise its 1997 guidance on 510(k) device modifications, rather than to more thoroughly revamp the policy.

Related Content


Latest Headlines
See All



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