Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Q&A: FDA’s LDT Inaction Catches Veteran Attorney Off-Guard

Executive Summary

Industry experts expected the US FDA to swiftly reverse a Trump-administration policy blocking oversight of lab-developed tests. Its inaction has one former agency attorney wondering why.

You may also be interested in...

FDA Widens Scope In Considering Evidence For Off-Label Use

After much wrangling, the US agency finally clarified its position on what evidence can determine "intended use" of a product – and industry is not happy.

Q&A: Unpacking The Latest VALID Act For Diagnostics

Covington & Burling partner Scott Danzis tells Medtech Insight why diagnostics developers and labs should keep an eye on the third iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act – reintroduced in the US Senate on 24 June – and why the bill has a better shot at becoming law this time.

Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs

Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.


Latest Headlines
See All



Ask The Analyst

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

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