- Industry Anticipates FDA Regulation of LDTs🔍
- FDA Proposes Rule Aimed at Helping to Ensure Safety and ...🔍
- The US FDA's New Rule for Regulating Laboratory|Developed Tests🔍
- Unpacking FDA's Final Rule to Regulate Laboratory Developed ...🔍
- Laboratory|Developed Tests🔍
- Navigating the FDA's New Rule on Laboratory Developed Tests and ...🔍
- FDA Intends To Regulate Many Clinical Labs as Medical Device ...🔍
- FDA Releases Highly Anticipated Final Rule on the Regulation of ...🔍
Industry Anticipates FDA Regulation of LDTs
Industry Anticipates FDA Regulation of LDTs - Jones Day
A proposed rulemaking from FDA to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
FDA Proposes Rule Aimed at Helping to Ensure Safety and ...
Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an ...
The US FDA's New Rule for Regulating Laboratory-Developed Tests
On May 6, 2024, the US Food and Drug Administration (FDA) finalized a new rule to regulate laboratory-developed tests (LDTs).
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 ...
Laboratory-Developed Tests: FDA Publishes Highly Anticipated ...
If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as medical devices ... Will the proposed rule change the industry's ...
Navigating the FDA's New Rule on Laboratory Developed Tests and ...
On May 6, the Food and Drug Administration (FDA) published a final rule setting out a new regulatory framework that phases out enforcement ...
FDA Intends To Regulate Many Clinical Labs as Medical Device ...
On May 6, 2024, the U.S. Food and Drug Administration (FDA or the Agency) published its highly anticipated final rule, which was formally ...
FDA Releases Highly Anticipated Final Rule on the Regulation of ...
This rule redefines in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs), as medical devices under the Federal Food, ...
Laboratory Developed Tests - FDA
Background; Increased FDA Oversight to Help Ensure Safety and Effectiveness of LDTs; Phaseout Policy; Webinars; Medical Device Regulatory Resources; Related ...
Four Strategic Questions About the Future of Diagnostics in the ...
In short, the final rule on this topic adds a single sentence to FDA regulations governing in vitro diagnostic products (IVDs), which will now ...
FDA's Final Rule on Laboratory-Developed Tests - Gibson Dunn
[2] In the LDT Final Rule, FDA amended its regulations to make explicit that LDTs fall within the definition of “device” under the Federal Food, ...
FDA Issues Final Rule Regulating Many LDTs as Medical Devices
The final rule amends FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FDCA), including ...
A Test of Patience: FDA Moves Forward with Controversial Final ...
FDA continues to hold firm that LDTs fit within the scope of its regulatory authority and that FDA regulation is necessary to ensure the safety ...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed ...
The US Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed ...
The Regulatory Headwinds Facing Lab-Developed Tests
The FDA has started to actively engage with the industry to help entities manufacturing LDTs understand the applicability and effects of this ...
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 ...
FDA's Proposed Rule on Laboratory Developed Tests - Akin Gump
... anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate ...
manufactured and offered as LDTs by laboratories that are certified under CLIA and that meet the regulatory requirements under CLIA to perform ...
FDA Takes Definitive Step Toward the Regulation of LDTs
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate ...
Forthcoming Regulatory Changes for Lab-Developed Tests - Avalere
This spring, the FDA will issue a rule to begin regulating LDTs as medical devices. A multi-faceted legislative, legal and market response is anticipated.