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

Lab Directors Look For Ways To Adjust To Proposed LDT Framework

This article was originally published in The Gray Sheet

Executive Summary

While many in the laboratory community protested loudly against FDA's plans to regulate lab-developed tests at a recent workshop, some tried to look ahead to how they could smoothly adjust to a dual regulatory system in which labs are regulated by CMS, while tests are approved by FDA.

You may also be interested in...



US Spending Bill Rider Looks To Stop Already Halted FDA LDT Guidance

A US FDA spending bill approved by the House Appropriations Committee July 12 would halt finalization of the agency's draft 2014 laboratory developed test guidance, recommending that FDA let Congress write its own bill directing any LDT regulation – but FDA already essentially handed the LDT reins to lawmakers last January.

Clinical Labs Lawyer Up In Battle Over LDTs

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.

FDA Releases LDT Regulatory Framework, Notification Draft Guidances

Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034067

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