FDA’s LDT Proposal, AI Oversight, Cybersecurity Top US Regulatory Interests In 2024

Staying The Course

Heading into 2024, the FDA’s Center for Devices and Radiological Health (CDRH) remains well-positioned to protect and promote the public health. Our plan is to stay the course and make good on the commitments we have already made, with a focus on continuing to advance medical device safety and innovation.

Health Equity

FDA’s work touches on environmental, social, and governance issues, particularly when relevant to its work concerning public health. Various statutes, regulations, and policies govern the FDA’s approach to these topics to ensure the safety and effectiveness of medical devices. This is evident as seen through the frame of HHS’ and CDRH’s stated priorities.

Strategic Goals

HHS’ first strategic goal is to Protect and Strengthen Equitable Access to High Quality and Affordable Healthcare, which dovetails with CDRH’s strategic priority to Advance Health Equity. This strategic priority continues to drive several workstreams of the CDRH in 2024, including expanding participation by diverse populations in evidence generation and developing a framework for when a device should be evaluated in diverse populations.

Additionally, areas of CDRH’s regulatory focus in 2024 are noted in the A list and B list of proposed guidance documents and inclusions on the Unified Agenda of Regulatory Actions.

With regard to uncertainties, the ramp-up in post-COVID enforcement activity brings with it a degree of uncertainty regarding how that enforcement will manifest itself (eg, increased warning letters, a predicted ramp-up in consent decrees, withdrawn CE marks). The degree to which FDA will enforce recently finalized and soon-to-be finalized rules and guidance (eg, cybersecurity, software, pre-determined change control plans, laboratory-developed tests, quality management systems regulation) is very much up in the air as well.

On October 3, 2023, FDA published a proposed rule that would result in regulating laboratory developed tests (LDTs) in the same manner as in vitro diagnostic (IVD) medical devices. If adopted as written, this rule would mean that thousands of laboratories would be regulated by FDA for the first time in history and would either need to comply with FDA requirements or discontinue their tests within four years of the effective date of the rule.

Tens of thousands of tests relied on my physicians and patients stand to be affected. This rule would profoundly shake up the laboratory industry and, because of the huge increase in workload for FDA, could significantly hinder FDA’s ability to effectively regulate other types of diagnostic devices. Thousands of stakeholders submitted comments to FDA in response to the proposed regulation, some of which strongly objected. A final rule is expected by mid-2024, perhaps with some minor modifications. If that happens, FDA will likely be sued.

In the meantime, the pendency of the proposal may lead Congress to revisit legislative proposals for LDT oversight. In sum, FDA’s proposed rule has led to significant uncertainty as to the fate of diagnostic regulation in the US.

One key uncertainty facing the medical device industry is how the US Food and Drug Administration’s proposed rule to actively regulate laboratory-developed tests will play out. The proposed rule would amend FDA regulations to make explicit that in vitro diagnostic products meet the definition of a 'device' under the Federal Food, Drug, and Cosmetic Act, including when the IVD manufacturer is a clinical laboratory. Driving the proposed rule (and FDA’s prior attempts to actively regulate LDTs) is its concern that results from faulty LDTs could cause unnecessary treatments or delay in or lack of proper treatment. This Agency concern is heightened by the fact that LDTs have become increasingly sophisticated and more efficient to run in larger capacities. These circumstances did not exist when FDA originally decided not to actively regulate LDTs as medical devices. The proposed rule is already being criticized by many clinical laboratory stakeholders, similar to preceding attempts by FDA to actively regulate LDTs. Actively regulating LDTs as medical devices may well trigger notable challenges. Many clinical laboratories would be drawn into the world of FDA-regulated manufacturers for the first time, facing new compliance costs and the significant effort needed to achieve and maintain FDA medical device compliance.

Which clinical laboratories would be able comply? Moreover, bringing LDTs into the actively regulated medical device fold will test an already busy FDA staff at the Center for Devices and Radiological Health and its limited resources. Will CDRH be able to effectively oversee LDTs and get the additional support it needs to do so?

This year may well tell us if FDA is able to keep pace with the rapidly developing artificial intelligence and machine learning technologies. These technologies, when integrated into medical devices, can make digital health more accessible and easier for patients while potentially further reducing the need for patients to directly interact with caregivers. One of the advantages of AI and ML-based device software functions is that they can improve and change their performance through iterative modifications as they gain experience. However, FDA’s traditional framework for the review of medical device changes requires the assessment of the change prior to its implementation which would tend to limit this advantage, possibly to the detriment of patients. In apparent recognition of this issue, FDA has introduced the concept of predetermined change control plans that would enable FDA to authorize anticipated AI/ML-based device modifications to device software products during the device’s original premarket review process. While this is a step in the right direction, FDA has not always earned high marks for regulatory flexibility, and it is uncertain if this measure will be adequate to keep the agency’s regulatory controls in pace with the advantages promised by AI and ML.

As we approach 2024, the medical device industry grapples with considerable uncertainties, notably in the realm of digital health where the FDA is poised to intensify enforcement activities. Over the past five years, the FDA has consistently communicated its authority and expectations in the digital health domain, and 2023 witnessed a uptick in enforcement actions against companies deviating from existing guidance and regulations. Anticipating a more pronounced regulatory stance in the upcoming year, both in terms of volume and severity, it becomes evident that the FDA's focus on the digital health landscape is set to expand. Particularly noteworthy is the FDA's planned 2024 updates to guidance in the artificial intelligence/machine learning sector, a domain ripe for enforcement given its rapid evolution. Industry stakeholders should prepare for heightened scrutiny and ensure alignment with evolving regulatory frameworks in the dynamic landscape of digital health and AI/ML applications in medical devices.

The unpredictable political and environmental climates, both figuratively and literally, could create instabilities to the device supply chain, as we saw with COVID-19. Even the threat of instability to the supply chain is a reminder that circular strategies focused on reuse, or in our case, commercially reprocessed single-use medical devices, keep more products domestic and available longer. The Joint Commission should take steps now to assure a more stable supply chain by driving circular economies and requiring FDA-regulated solutions like commercial reprocessing.