The FDA's Final Rule on LDTs

On May 6, 2024, the FDA issued a final rule aimed at helping to ensure the safety and effectiveness of laboratory developed tests (LDTs). The rule amends ...

Summary of LDT Rule: An In-depth Look at the Final ... - Venable LLP

In short, FDA sees the Final Rule as "correcting the imbalance in its oversight between non-laboratory and laboratory IVD manufacturers—an ...

Laboratory Developed Tests Regulatory Impact Analysis (Final Rule)

The annualized costs range from $566 million to $3.56 billion at a seven percent discount rate, with a primary estimate of $1.29 billion, and ...

Overview of FDA Laboratory Developed Test Final Rule - ASCP

Once fully implemented, the FDA generally will expect all IVDs—including LDTs—to meet FDA regulatory controls. As anticipated, the 528-page rule ...

Unpacking FDA's Final Rule to Regulate Laboratory Developed ...

On Monday, April 29, 2024, FDA announced the publication of its Final Rule to regulate laboratory developed testing services (LDTs) as medical ...

FDA issues final rule applying medical device rules to laboratory ...

The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion approach for most ...

The FDA's Final Rule on Lab-Developed Tests - ARUP Laboratories

Additional Webinars · The FDA released its final rule to regulate laboratory-developed tests (LDTs) on April 29, 2024. On May 29, 2024, the American Clinical ...

How to Comply with Stage One of the Laboratory Developed Tests ...

Some stakeholders are challenging this final rule in federal court, teeing up an argument on the scope of the FDA's authority to regulate LDTs ...

FDA's Final Rule on Laboratory-Developed Tests - Gibson Dunn

On April 29, 2024, the U.S. Food and Drug Administration (FDA) released its highly anticipated final rule on laboratory-developed tests (LDTs) ( ...

A Test of Patience: FDA Moves Forward with Controversial Final ...

On April 29, 2024, the U.S. Food and Drug Administration (“FDA”) issued its final rule affirming the Agency's position that laboratory ...

FDA Finalizes Rule and Sets Course to Phase In Oversight of ...

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory ...

Medical Devices; Laboratory Developed Tests - Federal Register

The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) ...

REGULATORY UPDATE: FDA Releases New Final Rule Describing ...

FDA's general enforcement discretion approach for LDTs will phase out over a period of four years and will be fully implemented by May 6, 2028.

The FDA's Final Rule on Laboratory-Developed Tests: FAQs

The rule makes it explicit that in vitro diagnostics (IVDs) that are manufactured by clinical laboratories—i.e., laboratory-developed tests (LDTs)—are ...

Key Takeaways from FDA's Final Rule on Laboratory-Developed Tests

The Final Rule makes clear that LDTs are now considered regulated medical devices and that FDA will phase out its LDT enforcement discretion policy over a four ...

What you need to know about the FDA Laboratory Developed Test ...

Under the new final rule, LDT manufacturers that generally operated outside FDA oversight will now be expected to come into compliance with ...

FDA Signals to Industry to Prepare for Compliance with the LDT ...

On May 6, 2024, the FDA issued the LDT Final Rule that makes clear that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act ...

House committee tells FDA to suspend lab developed test rule

In April, the agency finalized a rule clarifying that LDTs would be regulated as medical devices, similar to other in-vitro diagnostics, which ...

FDA Issues Final Rule Regulating Many LDTs as Medical Devices

The final rule states that LDTs generally will be subject to FDA's existing regulatory framework for medical devices by making explicit that IVDs are devices ...

FDA under fire: Pared-down LDT Final Rule leaves unanswered ...

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions ... The U.S. Food and Drug Administration (FDA) has finalized its historic — ...