On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are within the purview of the FDA.[2] The final rule will publish on May 6, 2024.[3] Until then, the unpublished version is available. [4]
The global IVD market is estimated to be about $82.4 billion in 2024.[5] IVD development was accelerated during the COVID-19 pandemic, in part due to a particularly facilitative regulatory environment. [6] During the FDA’s press release, Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said, “Through targeted enforcement discretion policies for certain categories of tests manufactured by a laboratory, we expect patients and health care professionals will continue to have access to the tests they need while having greater confidence that the tests they rely on are accurate.” [7]
In the past, the FDA had generally opted for discretionary non-enforcement of requirements for most laboratory developed tests. The final rule provides for a four-year, five-stage period during which the FDA will phase out this discretionary approach for many IVDs:
Stage 1 – starting May 6, 2025: Test makers are subject to medical device reporting requirements, correction and removal reporting requirements, and quality systems requirements relating to complaint files.
Stage 2 – starting May 6, 2026: Test makers are subject to registration and listing requirements, labeling requirements, and investigational use requirements.
Stage 3 – starting May 6, 2027: Test makers will be subject to all quality systems requirements.
Stage 4 – starting November 6, 2027: Test makers of high-risk IVDs—those classified into class III or subject to licensure under the Public Health Service Act—will be subject to premarket review requirements. Premarket submissions can be submitted to the FDA prior to Stage 4. In such instances, the FDA intends to continue to exercise enforcement discretion while the premarket submissions are under review.
Stage 5 – starting May 6, 2028: Test makers of moderate-risk and low-risk IVDs will be subject to premarket review requirements. Premarket submissions can be submitted to the FDA prior to Stage 5. In such instances, the FDA intends to continue to exercise enforcement discretion while the premarket submissions are under review. [8]
The phase out does not apply to all IVDs. The FDA will continue a policy of discretionary non-enforcement for “1976-Type LDTs,” certain Human Leukocyte Antigen tests, and tests intended solely for forensic purposes. [9] The FDA also intends to apply non-enforcement to LDTs manufactured and performed within the Department of Defense and the Veterans Health Administration. [10]
[1] FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests, FDA (April 29, 2024) (https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests).
[2] Id.
[3] Medical Devices: Laboratory Developed Tests. (visited April 30, 2024) (https://www.federalregister.gov/d/2024-08935)
[4] See 21 C.F.R. § 809, Docket No. FDA-2023-N-2177 (https://public-inspection.federalregister.gov/2024-08935.pdf).
[5] Global IVD Market Size, Share, Trends, COVID-19 Impact and Growth Forecast Report, Market Data Forecast (visited April 30, 2024) (https://www.marketdataforecast.com/market-reports/global-in-vitro-diagnostics-market).
[6] See Oyewole, Anne et al., COVID-19 Impact on Diagnostic Innovations: Emerging Trends and Implications, Diagnostics 11(2): 182 (January 27, 2021) (https://doi.org/10.3390/diagnostics11020182).
[7] FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests, FDA (April 29, 2024) (https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests).
[8] 21 C.F.R. § 809, Docket No. FDA-2023-N-2177 at 26–27. (Dates assuming publication of the final rule on May 6, 2024). It should be noted that the FDA’s classification of IVDs as low-, moderate-, or high-risk may depend partly on “whether the device is the sole determinant for clinical decision-making.” Id. at 361. Most high-risk IVDs test for infectious diseases where the risk of misdiagnosis could have severe repercussions for a patient. See CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs, FDA (January 31, 2024) (https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds).
[9] Id. at 27–28. “1976-Type LDTs” include tests that have characteristics common of LTDs offered in the year 1976. These characteristics include “(1) use of manual techniques (without automation) performed by laboratory personnel with specialized expertise; (2) use of components legally marketed for clinical use; and (3) design, manufacture, and use within a single [Clinical Laboratory Improvement Amendments (CLIA)]-certified laboratory that meets the requirements under CLIA for high complexity testing.” The type of human leukocyte antigen (HLA) tests that appear to be exempt from the phase out include those “that are designed, manufactured, and used within a single laboratory certified under CLIA that meets the requirements to perform high-complexity histocompatibility testing when used in connection with organ, stem cell, and tissue transplantation to perform HLA allele typing, for HLA antibody screening and monitoring, or for conducting real and ‘virtual’ HLA crossmatch tests”.
[10] Id. at 40.
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