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

Clinical Labs Lawyer Up In Battle Over LDTs

This article was originally published in The Gray Sheet

Executive Summary

ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.

You may also be interested in...



Take Care In Promoting Lab-Developed Genetic Tests Or Risk US FDA, FTC Ire

Device-practice attorneys provide tips and precautions for laboratories advertising and promoting non-cleared or unapproved molecular-based diagnostics, and avoiding enforcement.

Don't Finalize LDT Guidance, House Appropriators Tell FDA

FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.

Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions

FDA device center Director Jeff Shuren explained and defended fine points of FDA’s proposed laboratory-developed test framework before some of his sharpest critics: members of the American Clinical Laboratory Association, who face an entirely new regulatory scheme once the LDT proposal is finalized.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT033519

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