Medtech Insight is part of the Business Intelligence Division 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


Congress Will Not Tinker With FDA LDT Guidance Before Final, Staffers Indicate

This article was originally published in The Gray Sheet

Executive Summary

Both Democratic and Republican staffers on key congressional health committees say that members pushing forward a Senate “medical innovation” bill and backing “Cures” legislation in the House will not interfere with FDA’s proposed plan to regulate laboratory developed tests before the guidance is made final.


Related Content

Lab Group Urges FDA To Wait For Congress On LDT Issue
House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny
In Case You Missed It: Top 10 "Gray Sheet" Stories In September
Industry Challenges FDA's User Fee Markup
Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan
Latest FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts
Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers
Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules
Clinical Labs Lawyer Up In Battle Over LDTs
Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist





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