Laboratory Developed Tests

Keeping you up-to-date on the latest regulatory developments affecting laboratory developed tests (LDTs).

Our dedicated LDT page provides foundational materials, legislative and regulatory history, and updates and analyses regarding initiatives to increase oversight over LDTs, including FDA’s LDT Proposed Rule (October 2023).

Our Life Sciences Regulatory & Compliance team will continue to keep this page updated with the latest happenings.

Updates & Analysis

In Vitro Diagnostics (IVDs) Laboratory Developed Tests (LDTs)
Definition Reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae that are used in the collection, preparation, and examination of specimens taken from the human body. Tests that are intended for clinical use and that are designed, manufactured, and used within a high-complexity laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Regulatory Status Actively regulated by FDA as “devices” under the framework first established under the Medical Device Amendments of 1976 (MDA), which amended the Federal Food, Drug and Cosmetic Act to create a comprehensive system for the regulation of devices intended for human use. FDA has held (and has maintained its stance over the years) that LDTs are medical devices, but following enactment of the MDA, generally practiced discretion over enforcement of LDTs.

Following a decade of discourse with interested stakeholders, FDA published its proposed rule on October 3, 2023 that if finalized as proposed, would soon after subject the vast majority of LDTs to same regulatory requirements as in vitro diagnostics currently under the active oversight of the FDA, including for many LDTs, marketing authorization. Given in particular the significant growth in LDTs over the last decade, FDA’s proposal to subject LDT makers to more stringent oversight will be of significant interest to the laboratory testing industry.

Please see below for our analyses of the proposed rule:

Several legislative approaches for LDT regulation have been considered in recent years. The VALID Act is a longstanding legislative initiative that has been proposed in Congress several times over the last few years and would create an alternative regulatory regime for so-called “in vitro clinical tests” (IVCTs). IVCTs encompass both LDTs and IVDs, and as such would have a significant impact on the diagnostic industry at large.

FDA has regularly commented and issued information for the laboratory testing industry. We have assembled a related list of key resources. 

Contributing Editors