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


Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms

This article was originally published in The Gray Sheet

Executive Summary

Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.


Related Content

US Senators Press Agency Witnesses On Adding UDIs To Claims Forms
Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System
Party Leaders, Former St. Jude Exec Lead In Medtech Campaign Donations
Senators Debate Adding Unique Device IDs To Claims Forms
Sen. Murray Prods FDA To Clarify 510(k) Modification Policies In Superbug Bill
Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing
FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors
Patient, Consumer Groups Press For More Oversight Of Device Iterations
FDA Shoots For New 510(k) Modification Draft Guidance In 2016
Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers


Related Companies




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