FDA Finalizes Landmark Ruling: LDTs Officially Regulated as Medical Devices

The FDA issued a definitive ruling on laboratory developed tests (LDTs), categorically defining in vitro diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), regardless of whether they are manufactured in a laboratory setting.

The rule enacts a strategic four-year phaseout of the agency’s longstanding policy of general enforcement discretion for LDTs, marking a significant shift in regulatory oversight. This gradual phaseout reflects adjustments made in response to extensive public feedback, promoting test innovation and supporting scientific advances.

Increased oversight intended to reduce patient risk

The FDA historically exercised enforcement discretion for most Laboratory Developed Tests (LDTs), but modern LDTs pose greater risks due to their wider use, reliance on advanced technology, and potential for inaccurate results, leading to patient harm and increased healthcare costs.

Without increased oversight and compliance with FDA requirements, patients face the risk of receiving inaccurate test results, potentially leading to unnecessary treatment, delays in proper treatment, or worsened health outcomes. Enhanced regulation will promote confidence in all in vitro diagnostics (IVDs) and facilitate greater transparency in validation studies, potentially advancing health equity.

Final LDT Rule: FDA to Regulate LDTs as Medical Devices

At a glance — 

On April 29, 2024 the FDA announced a final rule to make explicit that IVDs are devices under the FD&C Act, including when the manufacturer is a laboratory.
The FDA’s enhanced oversight aims to mitigate potential patient harm and ensure the accuracy of test results.
The FDA’s strategic four-year phaseout of enforcement discretion for LDTs with certain exceptions.
See the article for Useful links and more.

Phasing out enforecement discretion for LDTs

The FDA’s policy to phase out its enforcement discretion for LDTs over four years aims to enhance public health by ensuring these tests’ safety and effectiveness, without disrupting patient care. This gradual phaseout reflects adjustments made in response to extensive public feedback, promoting test innovation and supporting scientific advances.

Post-phaseout, the FDA plans to align requirements for in vitro diagnostics (IVDs), whether produced by laboratories or non-laboratory entities, with some exceptions under targeted enforcement discretion policies. At the moment, these exceptions include:

Existing Marketed IVDs as LDTs: For IVDs marketed as LDTs before the final rule’s issuance, the FDA will exercise enforcement discretion to prevent potential loss of access to essential diagnostics.
Health System-Integrated LDTs: LDTs developed within a healthcare system for unmet needs, where no FDA-approved alternative exists, will also see enforcement discretion to ensure patient access to necessary tests.

Additional policies will apply to LDTs recognized by programs like New York State’s Clinical Laboratory Evaluation Program (CLEP), acknowledging their established review processes that help safeguard against risks associated with inaccurate tests.

Check back for more

Contact us with any questions you may have regarding the new FDA LDT Rule or the two new draft guidance documents. Stay tuned for additional information and tips to come from the MDC regulatory experts.