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

Lawmakers Plan Bill In Response To GAO Power Morcellator Report

Executive Summary

Several US House lawmakers are drafting a bill in response to a Government Accountability Office report finding that FDA's Medical Device Reporting system has shortcomings that may have missed adverse events for laparoscopic power morcellators. The devices have been linked to an increased risk of spreading cancer in women undergoing fibroid surgery.

You may also be interested in...



Pilot Of New US Evaluation System Will Include At Least Two Devices

New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.

FDA Turns Adverse-Event Reporting Scrutiny On Hospitals

The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.

Reps. Fitzpatrick, Slaughter Introduce Device Defect Reform Bills

Reps. Mike Fitzpatrick, R-Pa., and cosponsor Louise Slaughter, D-N.Y., introduced medical device reform bills that would let courts consider product liability suits for PMA-approved devices and require physicians to report to FDA adverse events involving medtech products.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104427

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