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


FDA Urged To Moderate Evidence Requirements In LDT Framework

This article was originally published in The Gray Sheet

Executive Summary

The agency will need to restrain evidence expectations for proving clinical validity in its planned framework for regulating laboratory-developed tests in order to make the framework more feasible, speakers at a Sept. 18 Avalere conference said.


Related Content

Experts Criticize FDA's Plan To Regulate Genomic Tests
FDA Releases LDT Regulatory Framework, Notification Draft Guidances
Will Lab-Developed Test Makers Be Subject To Device Tax? It Depends, Shuren Suggests At Hearing
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
Roche’s HPV Test Approved As First-Line Cervical Cancer Screen
Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway
FDA Approves First Next-Generation DNA Sequencing Platforms





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