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

Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions

This article was originally published in The Gray Sheet

Executive Summary

FDA device center Director Jeff Shuren explained and defended fine points of FDA’s proposed laboratory-developed test framework before some of his sharpest critics: members of the American Clinical Laboratory Association, who face an entirely new regulatory scheme once the LDT proposal is finalized.

Advertisement

Related Content

Diagnostics Reg Overhaul Floated In US House
Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go
FDA Puts Lab-Developed Test Oversight Plans On Hold
US FDA's Next-Gen Sequencing Guidances: One Stop On A Pathway
Lab Group Urges FDA To Wait For Congress On LDT Issue
New Fundings And Goals To Match Raised In Latest MDUFA IV Session
CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing
Clinical Labs Lawyer Up In Battle Over LDTs
FDA Releases LDT Regulatory Framework, Notification Draft Guidances
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions

Topics

Advertisement
UsernamePublicRestriction

Register

MT034615

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to 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

Add a personalized Question to your Analyst

Cancel