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


Diagnostics Reform Reintroduced in House

Executive Summary

The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.

You may also be interested in...

April Rule, Or April Fool? Will Final LDT Rule Be Ready On Time?

The White House has indicated that it expects the US FDA to publish its final rule on regulating lab-developed tests by April. But first, the agency must consider thousands of comments that have poured in since the proposal was published in October.

Hillebrenner Fields Questions On FDA’s Proposed Rule To Regulate LDTs, Says No To Extended Comment Period

During a recent webinar, Elizabeth Hillebrenner of the US FDA’s device center sought to clarify specifics on the agency’s proposed rule to regulate laboratory-developed tests, which establishes FDA oversight of the tests over a five-year period.

LDT Rule Will Have Massive Impact, Analysts Say; Fundamental Questions Remain

Stakeholders are still processing the US FDA’s proposed rule that would place lab-developed tests under its regulatory purview. While only time will tell what it all means, it is already clear that the agency’s action, if finalized, will significantly affect the healthcare industry and above all patients.

Related Content


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