Desjardins Discusses Priorities for Medical Device Industry in 2024
Life Sciences & Healthcare Regulatory partner Philip Desjardins was recently featured in the Medtech Insight article, “FDA’s LDT Proposal, AI Oversight, Cybersecurity Top US Regulatory Interests In 2024.” The article highlights views from industry experts and the U.S. Food and Drug Administration (FDA) on priorities and regulatory topics to watch in 2024.
Desjardins told Medtech Insight that the medical device industry is currently grappling with “considerable uncertainties, notably in the realm of digital health where the FDA is poised to intensify enforcement activities.” He said that a more “pronounced regulatory stance” is anticipated in 2024, both in terms of volume and severity, and that it is “evident that the FDA’s focus on the digital health landscape is set to expand.” He added that industry stakeholders should prepare for “heightened scrutiny” and ensure “alignment with evolving regulatory frameworks in the dynamic landscape of digital health and artificial intelligence/machine learning applications in medical devices,” particularly related to the FDA’s planned updates to guidance in these sectors in 2024.
