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

UsernamePublicRestriction

Labs Fear FDA’s Research-Use Dx Policy Could Shutter Some Testing Services

This article was originally published in The Gray Sheet

Executive Summary

Laboratories are worried that new FDA guidelines restricting sales of research-use and investigational testing products and instruments could effectively shut down screening for some conditions.

You may also be interested in...



Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

FDA Oversteps Its Bounds In Guidance On Research-Only Tests, Firms Say

Diagnostics companies say recent draft guidance on research-use and investigational tests oversteps FDA’s authorities by asking firms to police how customers ultimately use these products.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT030638

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

Cancel