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

Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan

This article was originally published in The Gray Sheet

Executive Summary

The Association for Molecular Pathology wants a Senate panel to consider a legislative alternative to FDA’s proposed lab developed test (LDT) framework, a plan to modernize the Clinical Laboratory Improvement Amendments Act and let CMS or a third party assess high-risk LDT procedures for clinical validity.

You may also be interested in...



Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.

Patient, Consumer Groups Press For More Oversight Of Device Iterations

Patient and consumer groups urged better FDA control over modifications to marketed products and expressed support for agency oversight of laboratory-developed tests at a recent update meeting on device user fee reauthorization.

House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny

A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034145

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