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


Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility

This article was originally published in The Gray Sheet

Executive Summary

Laboratory groups, who are facing the prospect of a new regulatory scheme in FDA’s proposed lab-developed test framework, intend to discuss barriers to test accessibility and clinical validation of LDTs in future comments.


Related Content

Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan
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
Flurries Of New Bills Advance Device Industry Interests In Congress
Would Expanded Lab-Test Regulation Overstep FDA’s Legal Limits?





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