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


FDA Begins Review Of Pre-amendments Device Data Submissions

This article was originally published in The Gray Sheet

Executive Summary

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution

You may also be interested in...

Congress Enters Final Stages On FDA Reform Bill

Legislative leaders say they remain on track to send FDA user fee reauthorization and reform legislation for the president’s signature by the end of June following House passage of bill.

Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4

Bipartisan FDA user fee reauthorization and reform legislation sailed unanimously through the House Energy and Commerce Committee May 10, with many similarities to a Senate version that has also passed out of committee.

FDA Panel Endorses PMAs For Electroshock Therapy Devices

A recent vote by an FDA advisory panel favoring more stringent regulation of electroconvulsive therapy devices is not likely to jeopardize future availability of the products on the market, according the panel's chairman.

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