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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Puts Lab-Developed Test Oversight Plans On Hold

Executive Summary

After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.

Advertisement

Related Content

Diagnostics In 2016: From Alere To Zika
What's Next For LDTs? FDA May Be Eyeing A New Game Plan
FDA And The Transition: Reading The LDT Leaves
Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go
Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests
MDUFA IV Takes Shape: A Catalogue Of Draft Commitments
Don't Finalize LDT Guidance, House Appropriators Tell FDA
Lab Group Urges FDA To Wait For Congress On LDT Issue
Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions
FDA Releases LDT Regulatory Framework, Notification Draft Guidances

Topics

Advertisement
UsernamePublicRestriction

Register

MT104114

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

Cancel