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.

Background

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.

What the Rule Changes

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:

• Expanded FDA oversight of many laboratory-developed tests
• A phased implementation schedule over several years
• Premarket review requirements for selected high-risk diagnostics
• New quality system and reporting obligations
• Limited exemptions for certain public health and academic laboratories

The proposed framework is intended to create greater consistency across diagnostic products while improving patient safety and transparency.

CPPC's Position

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."

What It Means for Patients

For patients, the immediate impact is expected to be minimal while implementation occurs over several years.

Long term, the proposal could:

• Increase confidence in diagnostic accuracy
• Improve consistency across certain laboratory tests
• Introduce longer timelines before some new tests become available
• Increase development costs for laboratories
• Affect availability of specialized or rare disease diagnostics if implementation is overly burdensome

CPPC believes careful implementation can balance patient safety with continued medical innovation.

What's Next

The FDA will continue reviewing public comments before issuing a final rule.

CPPC plans to:

• Continue participating in stakeholder discussions
• Advocate for evidence-based implementation timelines
• Publish additional policy updates as the rulemaking process advances
• Provide educational resources for healthcare providers, policymakers, and patients

As additional information becomes available, this page will be updated to reflect new developments.

Common Questions

Does this proposal affect tests currently available?

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.

Why is CPPC involved?

CPPC advocates for policies that protect patient access to innovative medical technologies while supporting responsible, science-based regulation.

When would the new regulations take effect?

The proposal includes a multi-year implementation schedule. Final timelines will depend on the FDA's final rule following review of public comments.

Where can I read CPPC's official response?

CPPC will publish its formal response and related policy resources in the Policy Framework section of the website once finalized.