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 Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs

Executive Summary

While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.


Related Content

Abbott Strikes Deal With British Liquid Biopsy Company Angle
Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future
US FDA Chief Favors LDT Approach In Bucshon-DeGette Bill
A New York Minute: US FDA Leverages State's Health Department To Expedite NGS Reviews
Q&A Exclusive: FDA Commissioner Talks About His Tenure, Recruiting And LDTs
US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests


Related Companies




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