Search Results: LDTs

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FDA Issues Final Rule on Regulation of Laboratory Developed Tests

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are devices under the Federal Food, Drug, and Cosmetic…

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FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review; Subcommittee on Health to Hold Hearing on Regulation of Diagnostic Tests

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory developed tests (“LDTs”) for administrative review.  Having swiftly moved to OIRA review in under 5-months from…

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FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding regulations under development by federal agencies. In its preamble, the Department of Health and Human Services (“HHS”) notes that…

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Newly Launched: Goodwin’s Laboratory Developed Tests Resource Page

Our Life Sciences Regulatory & Compliance team has launched a new resource page, keeping you up-to-date on the latest regulatory developments affecting laboratory developed tests (LDTs). Our dedicated LDT page provides foundational materials, legislative and regulatory history, and updates and analyses regarding initiatives to increase oversight over LDTs, including FDA’s…

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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy – Key Considerations & Open Questions

hands and test tube

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would implement a new “phaseout policy” that would, across five stages and within four years, apply the same regulatory requirements applicable to in…

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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over decade-long discourse amongst interested stakeholders – laboratories, IVD manufacturers, regulatory agencies, Congress, providers, and patients –…

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FDA Proposes Phased Approach to Regulating Laboratory Developed Tests

On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs).  If enacted, the proposed rule would amend the Agency’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under…

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