The U.S. Food and Drug Administration (FDA) has proposed a new regulatory pathway for laboratory-developed tests (LDTs) that could significantly change how diagnostic tests are reviewed before reaching patients. The Coalition to Protect Patient Care (CPPC) submitted formal comments outlining support for evidence-based oversight while emphasizing the importance of maintaining timely patient access to innovative medical technologies.
Laboratory-developed tests have historically been regulated under a unique framework that allows qualified laboratories to develop and perform specialized diagnostic testing without undergoing the same review process as commercially distributed medical devices.
The FDA's proposed rule would gradually bring many of these tests under expanded federal oversight. While the agency cites patient safety as the primary objective, stakeholders across healthcare have raised questions about implementation timelines, regulatory burden, and the potential impact on innovation.
Under the proposal, many high-complexity laboratory-developed tests would become subject to FDA review requirements similar to traditional in vitro diagnostic devices.
Key elements include:
The proposed framework is intended to create greater consistency across diagnostic products while improving patient safety and transparency.
CPPC supports efforts to strengthen patient confidence in diagnostic testing through evidence-based regulation. However, the coalition believes any new framework should preserve timely access to innovative technologies and avoid unnecessary duplication of existing oversight mechanisms.
The coalition recommends that implementation be guided by clinical evidence, practical timelines, and meaningful collaboration with laboratories, healthcare providers, and patient advocates.
"Patient access should remain the guiding principle of any regulatory modernization effort. Oversight should improve quality without delaying the availability of life-changing diagnostic technologies."
For patients, the immediate impact is expected to be minimal while implementation occurs over several years.
Long term, the proposal could:
CPPC believes careful implementation can balance patient safety with continued medical innovation.
The FDA will continue reviewing public comments before issuing a final rule.
CPPC plans to:
As additional information becomes available, this page will be updated to reflect new developments.
Most currently available laboratory-developed tests are expected to remain available during the proposed transition period. Any future compliance requirements would be phased in over time.
CPPC advocates for policies that protect patient access to innovative medical technologies while supporting responsible, science-based regulation.
The proposal includes a multi-year implementation schedule. Final timelines will depend on the FDA's final rule following review of public comments.
CPPC will publish its formal response and related policy resources in the Policy Framework section of the website once finalized.