On December 4, 2023, the public comment period for the US Food and Drug
Administration's(FDA) proposed rule to regulate laboratory-developed tests (LDTs) as …

In October 2023, the US Food and Drug Administration (FDA) released a proposed rule to
regulate laboratory-developed tests (LDTs) as medical devices. While approximately 6,700 …

ABSTRACT In October 2023, the US Food and Drug Administration (FDA) released a
proposed rule to regulate laboratory-developed tests (LDTs) as medical devices. While …

In 2010 the US Food and Drug Administration (FDA) 7 stated that it would issue guidance on
its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a …

* Address correspondence to this author at: Department of Pathology, Microbiology, and
Immunology, Vanderbilt University School of Medicine, 1301 Medical Center Drive, 4605 …

Objectives To solicit quantifiable feedback from clinical laboratorians on the US Food and
Drug Administration (FDA) proposed rule to regulate laboratory-developed tests (LDTs) as …

January 2024| 09: 01| 155–158| JALM 155 results could lead to patient harm, many of these
claims are based on potential inappropriate actions by providers interpreting test results and …

ABSTRACT In October 2023, the Food and Drug Administration (FDA) released a proposed
rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's …

Although the VALID act failed to advance through Congress and become law in early 2023,
it was disappointing to see a new attempt by the US FDA to change the regulatory paradigm …

The FDA published a final rule for Medical Devices; Laboratory Developed Tests in the
Federal Register on May 6, 2024, which aims to ensure the safety and effectiveness of …