Medical Device Partners Neil O’Flaherty and Evan Phelps Highlight FDA’s Regulatory Interests in 2024
One fundamental 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.
Which clinical laboratories would be able to 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 tell us if FDA can 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 interact with caregivers directly. 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 before its implementation which would tend to limit this advantage, possibly to the detriment of patients.
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