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February 22, 2024

FDA Started a Process to “Downclassify” Most High-Risk IVD Types: Here Is Why


On January 31, the U.S. Food and Drug Administration (FDA or the Agency) announced that the Center for Devices and Radiological Health (CDRH) intends to begin the reclassification process for most in vitro diagnostics (IVDs) that are Class III (high-risk devices) into Class II (moderate-risk devices). Most of these are infectious disease and companion diagnostic IVDs, and their reclassification would enable manufacturers of these tests to seek marketing authorization through the 510(k) clearance pathway rather than the more rigorous pre-market approval (PMA) pathway. The Agency explained that reclassification may “support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests.” Though the proposal does not explicitly reference FDA’s proposals to regulate laboratory-developed tests (LDTs), we believe this reclassification proposal is another readiness step in the direction of LDT regulation for the reasons discussed below.

What Is FDA Doing?

CDRH will propose reclassifying IVDs for which it believes there is sufficient information to establish special controls that will provide reasonable assurances of safety and effectiveness for these tests when taken together with general controls. FDA explained that CDRH has begun this process, citing to a September 2023 meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee during which the panel made recommendations concerning potential reclassification from Class III to Class II with special controls for three types of infectious disease IVDs.

In addition, CDRH will continue employing a risk-based approach when initially classifying IVDs to determine the appropriate level of regulatory controls. This includes determining whether a new IVD can be Class II with special controls through the De Novo Classification pathway as opposed to being Class III. Notably, FDA stated that it believed “special controls could be developed, along with general controls, that could provide a reasonable assurance of safety and effectiveness for most future companion diagnostic and infectious disease IVDs” and, as such, these tests would be regulated as Class II devices.

Why Now?

While CDRH periodically conducts classification reviews to ensure devices are being regulated in the appropriate class and subject to appropriate regulatory controls, we believe that the timing of this action may relate to the anticipated final rule to regulate LDTs as IVDs, which would require high-risk tests to undergo the PMA pathway and moderate-risk tests to undergo the 510(k) clearance pathway as described in our Advisory on this subject. CDRH’s proposed reclassification would shift most types of IVDs that are currently subject to the PMA pathway to the 510(k) pathway. This could result in significantly less LDTs being subject to the PMA pathway and, thus, potentially lessen both laboratories’ and FDA’s burden in preparing and reviewing, respectively, premarket submissions for LDTs once those requirements are effective. It would also have the effect of lowering the burden and uncertainty facing personalized medicine developers whose biomarker-specific therapeutic development and commercialization strategy has hereto been subject to the challenge and additional uncertainty of managing their New Drug Application/Biologics License Application submission with a synchronous diagnostic company’s CDRH submission, a delay in which could delay commercial availability of the therapeutic. More generally, FDA could use the reclassification step to later argue that the economic burden of the final rule is not as substantial on industry and the Agency as rule critics anticipated.

It is unclear how quickly FDA intends to, or is capable of, reclassifying these IVDs. In 2009 CDRH initiated a formal process to evaluate and potentially reclassify 32 pre-amendment Class III devices for which regulations requiring submission of PMAs had not yet been issued. This reclassification effort took 10 years, largely due to competing public perspectives on the risk level and appropriate classification of each device. Separately, in recent years, FDA has reclassified a number of post-amendment IVDs from Class III to Class II, including certain hepatitis C virus ribonucleic acid tests, hepatitis C virus antibody tests, and human immunodeficiency virus viral load monitoring tests.1 Given the anticipated timeline for implementation of the LDT final rule and Agency learnings from the 2009 reclassification initiative, we anticipate FDA plans to complete this reclassification process in advance of current high-risk LDTs being subject to FDA premarket review (the proposed rule indicated three and one-half years after publication of the final rule).

We also note that, in June 2023, FDA launched a voluntary pilot program to help reduce the risks associated with using LDTs to identify cancer biomarkers. The program is intended to address situations where FDA approves an oncology drug that requires use of a companion diagnostic IVD to identify whether a patient has certain biomarkers, although the companion diagnostic IVD has not yet been approved or cleared, and, thus, clinicians rely on LDTs to make treatment decisions. Through the pilot program, FDA will publish minimum performance standards to support better and consistent performance of LDTs to detect biomarkers for drugs in the program. Because companion diagnostic IVDs are typically subject to the PMA pathway, FDA’s reclassification of most types of companion diagnostic IVDs could help these tests reach the market faster in the future via the 510(k) pathway and, thus, limit or eliminate periods of time where clinicians need to rely on LDTs to make drug-related treatment decisions.

Next Steps

As noted, CDRH will begin proposing Class III IVDs for which it believes special controls, together with general controls, provide reasonable assurance of safety and effectiveness for reclassification to Class II devices. The Agency will publicly communicate any new information as it becomes available.

© Arnold & Porter Kaye Scholer LLP 2024 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. In addition, although not reclassification orders, FDA has identified certain Class I and Class II devices that it determined no longer require 510(k) clearance pursuant to Section 3054 of the 21st Century Cures Act.