- ADLM June survey results of clinical laboratories regarding FDA ...🔍
- Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot ...🔍
- Proposal to Phase Out FDA Enforcement Discretion for Lab ...🔍
- Overview of FDA Laboratory Developed Test Final Rule🔍
- FDA Issues Final Rule on Laboratory Developed Tests 🔍
- FDA's Final Rule on LDTs and Its Impact on Clinical and Regulatory ...🔍
- ARUP Laboratories To Host Informational Webinar on the FDA's ...🔍
- FDA targets more oversight of lab|made tests🔍
Industry Anticipates FDA Regulation of LDTs
ADLM June survey results of clinical laboratories regarding FDA ...
A graph showing that 69% of labs anticipate discontinuing LDTs due to the FDA's regulatory. ADLM looks forward to working with you on this ...
Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot ...
In these cases, tests offered as laboratory developed tests (LDTs) are being used for patient treatment decisions. FDA has generally exercised ...
Proposal to Phase Out FDA Enforcement Discretion for Lab ...
FDA History of Regulating LDTs ... Historically, the FDA has not actively regulated most LDTs under a longstanding policy of enforcement ...
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 ...
FDA Issues Final Rule on Laboratory Developed Tests (LDTs ...
FDA initially proposed this rule in October 2023 after years of deliberation regarding the regulation (or lack thereof) of LDTs. The Final Rule ...
FDA's Final Rule on LDTs and Its Impact on Clinical and Regulatory ...
In 2023, the FDA made public a potentially game-changing proposal concerning the regulatory framework for LDTs. Learn more about the change ...
ARUP Laboratories To Host Informational Webinar on the FDA's ...
Nearly 85% of respondents to an ARUP Laboratories survey on the impact of the FDA's proposed rule to regulate laboratory-developed tests (LDTs) ...
FDA targets more oversight of lab-made tests - Axios
The big picture: The Food and Drug Administration on Friday rolled out a plan to regulate lab-developed tests that have long escaped close ...
FDA's proposed rule for the regulation of laboratory-developed tests
The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), ...
The LDT Final Rule Goes Into Effect Today - King & Spalding
In addition, laboratories should understand that FDA considers their LDTs to be FDA-regulated medical devices today, even if FDA is not yet ...
FDA proposes new regulations to increase oversight of Laboratory ...
FDA's proposed phased approach to regulating Laboratory Developed Tests (LDTs) presents a seismic shift to the viability of current ...
FDA Finalizes Rule to Assert Authority Over Laboratory Developed ...
The Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed tests (LDTs) as in vitro ...
FDA holds firm on 60-day comment period for lab-developed test rule
The agency unveiled its much-anticipated proposal to increase oversight of LDTs on Oct. 3, starting the clock ticking on the comment period. The ...
The US FDA's proposed rule on laboratory-developed tests
To solicit quantifiable feedback from clinical laboratorians on the U.S. Food and Drug Administration (FDA) proposed rule to regulate laboratory-developed ...
FDA Draft LDT Guidance Slated for Release in 60 Days - GenomeWeb
... anticipated" document. ... ACLA, which has long battled against FDA regulation of its industry ... FDA regulation of LDTs may still come up in ...
Regulation of Laboratory-Developed Tests | FDA Update
Several categories of new and significantly modified LDTs would also be exempt from agency's premarket review, QSR, and registration and listing ...
The FDA is Coming After Your Lab Developed Test (LDT) - LinkedIn
FDA's anticipates that premarket review will only be required for certain tests (generally those classified into class II or class III) and is ...
Although the LDT regulatory process offers labs significant flexibility and enables a more rapid response to public health needs when no FDA-cleared or - ...
Laboratory-Developed Test Oversight FAQs
The FDA's final rule regulating laboratory-developed tests as medical devices put forth a lot of changes which has been met with just as many questions.
Statement Of Alan Mertz, President, The American Clinical ...
The FDA cannot newly regulate an entire industry sector ... Additionally, FDA regulation of LDTs as medical devices would dramatically slow not.