--- title: "LDT, Laboratory-Developed Test | MedTech Terms" description: "IVD designed, manufactured, and used within a single CLIA laboratory. Plain-English Market Segments definition for MedTech teams, with examples and related term" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ldt#term", "name": "Laboratory-Developed Test", "alternateName": "LDT", "description": "LDTs are diagnostic tests developed and performed by a single high-complexity CLIA-certified laboratory rather than distributed as kits. 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The specific impact will depend on the phase and type of LDT, with a transition period provided for laboratories to meet the new standards." } }, { "@type": "Question", "name": "What is the role of CLIA in LDTs after the FDA's rule?", "acceptedAnswer": { "@type": "Answer", "text": "CLIA continues to regulate the analytical and clinical validity, as well as the overall quality of laboratory testing. The FDA’s new rule focuses on the safety and effectiveness of the LDTs as medical devices. CLIA regulations will remain critical for ensuring the operational quality of the laboratory itself." } }, { "@type": "Question", "name": "Are there specific types of LDTs that may be exempt from the new FDA regulations?", "acceptedAnswer": { "@type": "Answer", "text": "The final rule outlines certain exemptions and enforcement discretion policies for specific categories of LDTs, such as those for rare diseases or for use in public health emergencies, though these are limited and subject to specific criteria. Laboratories should consult the final rule and FDA guidance for precise details on exemptions." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Laboratory-Developed Test [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape)LDT # Laboratory-Developed Test IVD designed, manufactured, and used within a single CLIA laboratory. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition LDTs are diagnostic tests developed and performed by a single high-complexity [CLIA](/terms/clia)\-certified laboratory rather than distributed as kits. FDA historically exercised enforcement discretion; a 2024 final rule began phasing in active oversight. What the regulation says The FDA, under the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act, has the authority to regulate [in vitro diagnostics](/terms/ivd) (IVDs), which include Laboratory-Developed Tests (LDTs). While the FDA historically exercised enforcement discretion, the [Medical Device User Fee Amendments](/terms/mdufa) of 2022 (MDUFA V) included provisions setting the stage for increased FDA oversight of LDTs. The [Clinical Laboratory Improvement Amendments](/terms/clia) (CLIA) of 1988, administered by CMS, regulate the quality of laboratory testing regardless of where tests are performed, ensuring accuracy, reliability, and timeliness of patient test results. ## What this means in practice Many oncology, infectious disease, and rare-disease tests reached patients as LDTs. The FDA LDT rule, ongoing litigation, and CMS [PAMA](/terms/pama) repricing are key uncertainties. ## Examples - A hospital laboratory develops a novel genetic test for a rare inherited condition, performing all aspects of the test in-house with CLIA certification. - A commercial reference laboratory creates a new diagnostic assay for a difficult-to-culture infectious agent, offering it to healthcare providers as a service. - A university research lab validates a personalized diagnostic test to predict therapeutic response for specific cancer patients, adhering to CLIA standards for its operational processes. Common pitfalls - • A key misconception is that CLIA certification alone is sufficient for regulatory compliance of an LDT. - • Some assume that all LDTs are exempt from FDA regulation, which is no longer the case with the implementation of new oversight. - • Neglecting to consider the phased implementation schedule of the FDA’s new LDT rule can lead to significant compliance gaps. ## Frequently asked questions How does the FDA's new rule impact existing LDTs? The FDA's new rule is expected to phase in requirements for LDTs, potentially subjecting them to the same regulatory requirements as other [in vitro diagnostics](/terms/ivd), including premarket review, quality system regulations, and [adverse event](/terms/adverse-event) reporting. The specific impact will depend on the phase and type of LDT, with a transition period provided for laboratories to meet the new standards. What is the role of CLIA in LDTs after the FDA's rule? Are there specific types of LDTs that may be exempt from the new FDA regulations? ## Cross-references ### Governed by Regulations or standards this term must comply with. - [ Clinical Laboratory Improvement Amendments(CLIA) ](/terms/clia) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Clinical Laboratory Improvement Amendments(CLIA) U.S. federal standards that govern clinical laboratory testing. ](/terms/clia)[ Market Segments In Vitro Diagnostics(IVD) Tests performed on biological samples outside the body. ](/terms/ivd) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 AdvaMed· 1 MedTech Europe· 1 1. [1 FDA LDT final rule Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests) 2. [2 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Acronym LDT Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ldt) Learn in 60 seconds Card Lesson Quiz IVD designed, manufactured, and used within a single CLIA laboratory. - · Many oncology, infectious disease, and rare-disease tests reached patients as LDTs. - · The FDA LDT rule, ongoing litigation, and CMS PAMA repricing are key uncertainties. - · FDA historically exercised enforcement discretion; a 2024 final rule began phasing in active oversight. Remember this Watch out: A key misconception is that CLIA certification alone is sufficient for regulatory compliance of an LDT. Related terms - [In Vitro Diagnostics(IVD) ](/terms/ivd) - [Clinical Laboratory Improvement Amendments(CLIA) ](/terms/clia) You may also need Auto-suggested from Market Segments and shared keywords. - [Point-of-Care Diagnostics(POC) ](/terms/point-of-care) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Proprietary Laboratory Analyses Codes(PLA) ](/terms/pla-codes) - [In Vitro Diagnostics (Segment)(IVD) ](/terms/ivd-segment) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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