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


Sen. Grassley Seeks More Documents From Northwestern On Edwards’ Valve Inquiry

This article was originally published in The Gray Sheet

Executive Summary

The Iowa Republican says Northwestern Memorial Hospital may have held back materials in response to his 2008-launched inquiry into use of an Edwards Lifesciences heart valve repair device without FDA clearance or proper patient consent.

You may also be interested in...

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.

Grassley Wants More Active FDA Oversight Of 510(k) Modification Decisions

Sen. Chuck Grassley, R-Iowa, is questioning why FDA does not play a more active role in determining when a change to a device requires a new 510(k)

Edwards’ Mitral Valve Repair Device Withdrawn, Under Scrutiny

Edwards Lifesciences removed a mitral valve repair device from the market in October and submitted a 510(k) for the product in the midst of an FDA inquiry into whether the device was being marketed without proper clearance


Related Companies

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