On May 6, 2024, the US Food and Drug Administration (FDA) finalized a new rule to regulate laboratory-developed tests (LDTs). An LDT is a reagent, instrument, or system used for diagnosis or treatment that is designed, manufactured, and used by a single laboratory.1LDTs a...
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaitedfinal rulethat laboratory developed tests (LDTs) will be regulated as medical devices. LDTs arein vitrodiagnostic products (IVDs) that are intended for clinical use a...
designed, manufactured, and used within a single laboratory). However, FDA proposes not to extend the phaseout to certain tests it asserted were generally excluded from the scope of the current enforcement discretion
Sharfstein, J., 2015. FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science. JAMA 313 (7), 667.Sharfstein J. FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science. JAMA 2015;313:667-8....
Regulation of laboratory-developed tests has been a subject of debate since at least the 1990s. Several federal advisory committees, including the Institute of Medicine, have recommended that the FDA exercise more authority over such testing. That's also been the position of diagnostic test manufactu...
FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy – Key Considerations & Open Questions
Tthe U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many yea...
The FDA warning letter to Agena marks a shift in enforcement, targeting the improper labeling of laboratory-developed tests and RUO products without approval.
Contains Nonbinding Recommendations Draft - Not for Implementation 1 2 Draft Guidance for Industry, Food and 3 Drug Administration Staff, and Clinical 4 Laboratories 5 6 7 Framework for Regulatory Oversight of 8 Laboratory Developed Tests (LDTs) 9 10 DRAFT GUIDANCE 11 12 13 This guidance document...
tests. The U.S. Food and Drug Administration’s (FDA) recent final rule now explicitly designates Laboratory Developed Tests (LDTs) as devices under the Federal Food, Drug, and Cosmetic Act. This move aims to enhance the safety and effectiveness of LDTs used in a single clinical laboratory...