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MedTech Dive8d
FDA declines to appeal court order that stopped LDT final rule
The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...
The National Law Review1y
LDT Final Rule Series: Part 2 – Response to the Rule
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...
American Hospital Association8d
FDA doesn’t appeal court ruling invalidating lab-developed tests rule, effectively eliminating it
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...
Hosted on MSN2mon
FDA’s LDT rule struck down in Texas court
Upon the Final Rule’s release last year ... the diagnostics industry at a ‘practical standstill’. "FDA’s LDT rule struck down in Texas court" was originally created and published by ...
Hosted on MSN7mon
FDA LDT litigation could be ‘train wreck in the courts’
Litigation against the FDA's Final Rule on lab-developed tests (LDTs ... The first deadline for the LDT rule transition timeline is May 6, 2025, and while manufacturers have been watching to ...
Healthcare Dive7mon
5 steps to navigate the FDA’s new lab developed test rule
In a major shift, most tests designed by individual labs for in-house use must meet Food and Drug Administration requirements for medical devices under a final rule published in May. Those ...
Yahoo Finance10mon
In Response to FDA LDT Final Rule, LISA Launches Crowdfunding Initiative for Clinical Laboratories
He concluded, "We believe with LISA resources and support, our members will be able to successfully navigate all phases of the Final FDA LDT rule." Key Players in LISA LISA brings together ...
FDA Skips Move to Revive Suit Over Agency’s Lab Test Authority
The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...
Healthcare Dive11mon
House committee tells FDA to suspend lab developed test rule
Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs). The House Appropriations Committee made the request ...