Medtech Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Lawmaker Asks FDA To Launch Criminal Inquiry Into Power Morcellators

This article was originally published in The Gray Sheet

Executive Summary

Rep. Mike Fitzpatrick, R-Pa., is asking FDA's criminal office to investigate whether Ethicon and several East Coast hospitals fulfilled safety reporting requirements for power morcellators, which have been linked to a risk of spreading cancer in women undergoing treatment for uterine fibroids.

You may also be interested in...



Lawmakers Plan Bill In Response To GAO Power Morcellator Report

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.

'Cures' Bill Passes, As More Budget, Safety Debates Wait In The Wings

The 21st Century Cures bill passed on a 344-77 vote, attracting significant bipartisan support in the House. It includes multiple provisions supported by the device industry, including a priority review pathway for breakthrough devices. Attention now moves to the Senate, which is working on its own bill that could face budget barriers and calls for more safety protections.

EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

Topics

Related Companies

UsernamePublicRestriction

Register

MT034758

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

Cancel