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Laboratory Developed Tests

The FDA defines Laboratory Developed Tests (LDTs) as “in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements.”  Since LDTs play such an important role in healthcare today and the fact that the FDA has seen an increase in general concerns about the safety and effectiveness of LDTs, the FDA has been working on increased oversight.


This increased oversight has been captured in a proposed rule that aims to uphold the safety and effectiveness of LDTs.  Per the FDA, “The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs through a phaseout of its general enforcement discretion approach for most LDTs.”


Manufacturers of IVDs, even if that manufacturer is a laboratory, will need to ensure that they seek the proper approvals or clearances in accordance with the current medical device classification structure.  The following FDA Medical Device classifications that OnemataDC shared in our article, U.S. Medical Device Regulations, will be applied, dictating the pre-market path for IVD manufacturers and laboratories:


  • High risk devices (Class III) – Premarket Approval (PMA) is required

  • Low (Class I) to moderate (Class II) risk devices

    • De Novo Classification Request – required when there is no legally marketed predicate device

    • Premarket Notification 510(k) – required when there is a legally marketed predicate device


FDA is reviewing the IVD classifications to determine if any can be down-classified from Class III to Class II, or Class II to Class I. OnemataDC expects there to be significant action by FDA on IVD classification and you can learn more here. While this is an extremely brief description of the upcoming rule change, OnemataDC’s team is up to speed on this important change and has technical experts to help you successfully navigate this new enforcement reality – reach out today!

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