On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) outlined its prospective guidance agenda for the 2025 fiscal year concerning medical devices, notably addressing the growing impact of advanced technologies such as artificial intelligence (AI). This announcement, made under the Biden administration, includes a comprehensive array of proposed guidance documents aimed at modernising the regulatory approach to medical devices, particularly with a focus on AI-enabled functionalities.
The proposed guidance agenda is categorised into three tiers of priority: an A-list, which encompasses the agency's primary focus areas; a shorter B-list; and an "Under Construction" list, highlighting those documents that are still in development due to resource constraints. Key issues addressed by the agenda include the utilisation of real-world evidence in device submissions and the evolving regulatory framework for laboratory developed tests (LDTs).
Among the pivotal A-list documents is the final guidance on the enforcement discretion policy regarding LDTs, which responds to the 2024 final rule aimed at phasing out the previous enforcement discretion approach. Additionally, the guidance document on the Q-Submission Program delineates best practices for manufacturer interactions with the FDA, while the agency's stance on the use of real-world evidence is also clarified. Emphasising AI, the agenda includes a document titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions,” providing guidance on structuring premarket control plans for devices with expected modifications.
Troy Tazbaz, the Director of FDA's Digital Health Center of Excellence, discussed the significance of a lifecycle management framework for AI-enabled medical devices in a blog post published in July 2024. CDRH is responding to these developments with a draft guidance document that focuses on lifecycle management considerations, signalling an increasing commitment to regulate technologies that leverage generative AI effectively.
The B-list features a draft guidance document revising previous recommendations on mobile medical applications while addressing the regulatory status of software functions integral to device technologies. The “Under Construction” category includes various guidance documents that will assist in addressing complex issues surrounding digital health and in vitro diagnostic devices — bolstering the regulatory framework as technological capabilities evolve.
CDRH also anticipates finalising several regulations affecting medical devices in 2025. This includes proposed rules for creating procedures regarding suspensions of clinical investigations and classifying minimally manipulated allograft heart valves as Class III devices, alongside various proposals related to tissue-based products.
As the FDA seeks to modernise its processes and regulatory frameworks, it has invited stakeholder comments on each proposed guidance, reflecting an ongoing dialogue about how best to adapt to the rapid advancements in medical technologies, particularly those driven by AI and machine-learning innovations.
Source: Noah Wire Services