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MedTech Dive9d
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 ...
Hosted on MSN1mon
The FDA’s Final Rule on LDTs: gone for good?
In May 2024, the US Food and Drug Administration (FDA) issued its ‘Final Rule’, asserting that laboratory-developed tests (LDTs) - otherwise known as in vitro diagnostics (IVDs) - were medical ...
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 ...
Yahoo Finance7mon
FDA’s final rule on LDTs causes concern, but timeline looks unsteady
Critics, the US presidential election and a lawsuit are putting the reclassification of laboratory-developed tests (LDT) as medical devices in jeopardy, analysts have said. The US Food and Drug ...
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 ...
The National Law Review2mon
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final 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 ...
Healthcare Dive7mon
5 steps to navigate the FDA’s new lab developed test rule
The final rule phases out the FDA’s prior “enforcement discretion” approach to LDTs in five stages over four years. Stage 1, which begins May 6, 2025, mandates compliance with medical device ...
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 ...
Business Wire10mon
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 ...
The National Law Review2mon
A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
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 ...