Patient Care First

Get guidance and resources for the FDA’s Final Rule so your LDTs remain available to those who need them most.

Understand the key aspects of the FDA Final Rule for LDTs.
Learn about the phaseout policy and timeline.
Identify the types of tests included and excluded from the rule.
See the implications of the rule for clinical laboratories.

Get Your Free FDA Reference Guide

See a step-by-step overview of the FDA’s regulations, phaseout timeline and policy, lab implications and more!

Why Do We Care About What Happens To Your LDTs?

ELITech specializes in esoteric testing, providing advanced diagnostic solutions that address complex and often unmet needs in patient care. We deeply understand the critical role that Laboratory Developed Tests play, especially when no commercially cleared tests exist for rare diseases. Because of this, we are dedicated to ensuring that patients receive the care they need, even in the face of evolving regulations.

We are here to provide tools and resources for your lab so you can feel confident navigating through this new regulatory landscape.

Get Your Free FDA Reference Guide

FDA Final Rule

Understand the key aspects of the FDA Final Rule for LDTs.
Phaseout Timeline

Learn about the phaseout policy and timeline.
Test Types

Identify the types of tests included and excluded from the rule.
Implications

See the implications of the rule for clinical laboratories.

Get My Reference Guide Now

Who is ELITech?

At ELITech, we are leaders in providing innovative diagnostic solutions to laboratories around the world. With decades of experience in the industry, our mission is to empower labs with the tools and knowledge they need to deliver accurate, reliable, and timely diagnostics. We are committed to supporting our partners through every regulatory change, ensuring that patient care remains at the forefront of everything we do.

Frequently Asked Questions

The FDA’s phaseout policy is a gradual process that will bring LDTs under the same regulatory framework as other in vitro diagnostics (IVDs). This policy includes a staged timeline for compliance, where different requirements will be enforced at specific intervals over the next few years.

Certain tests are excluded from the scope of the phaseout policy, including tests intended solely for forensic purposes, tests used within the Department of Defense (DoD) or the Veterans Health Administration (VHA), and 1976-type LDTs that use manual techniques and are performed within a single laboratory.

Enforcement discretion refers to the FDA’s decision to not fully enforce certain regulatory requirements for specific categories of LDTs. This means that while the FDA has the authority to regulate these tests, they may choose not to enforce certain rules to allow labs time to adapt.

The phaseout timeline consists of five key stages, starting with the implementation of medical device reporting requirements in 2025, followed by registration and listing requirements in 2026, and culminating with the requirement for premarket review submissions for moderate and high-risk tests by 2028.

Questions?

We’re here to support you as you navigate the new FDA regulations—feel free to reach out with any questions or concerns.

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Patient Care First

Get Your Free FDA Reference Guide!

Get Your Free FDA Reference Guide

Why Do We Care About What Happens To Your LDTs?

Get Your Free FDA Reference Guide

FDA Final Rule

Phaseout Timeline

Test Types

Implications

Who is ELITech?

Frequently Asked Questions

Questions?