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

Flurries Of New Bills Advance Device Industry Interests In Congress

This article was originally published in The Gray Sheet

Executive Summary

The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.

You may also be interested in...



Burgess Still Wants to Limit FDA LDT Oversight

Despite failing to move on a bill to restrict FDA oversight of lab developed tests (LDT) or reintroducing the bill in recent sessions, Rep. Michael Burgess, R-Texas, says he still supports the idea and is still working on trying to limit the agency's authority.

Rep. John Shimkus, Architect Of Cures Bill Device Reform Provisions

Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility

Laboratory groups, who are facing the prospect of a new regulatory scheme in FDA’s proposed lab-developed test framework, intend to discuss barriers to test accessibility and clinical validation of LDTs.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT030633

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