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


Don't Finalize LDT Guidance, House Appropriators Tell FDA

This article was originally published in The Gray Sheet

Executive Summary

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.


Related Content

FDA Puts Lab-Developed Test Oversight Plans On Hold
House-Senate Conferees Fight Over Zika Funds As FDA Approves More Assays
In Case You Missed It: Top 10 Gray Sheet Stories In April
Quest Wins First Commercial Zika Test FDA Emergency-Use Approval
Califf Puts Weight Behind 'Sentinel' As Evidence-Generation System Of The Future
CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing
House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny
Clinical Labs Lawyer Up In Battle Over LDTs
FDA Releases LDT Regulatory Framework, Notification Draft Guidances





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