CONTEXT: An interesting article highlighting the FDA’s position on RWR in the rapidly developing field of AI within SaMD. Within the proposed FDA framework, in the post-marketing realm, quote “the Proposed Framework also encourages manufacturers to leverage real-world performance data and monitoring to understand how their products are being used in the real world, and enable them to respond more proactively to safety and risk issues that may emerge.”
IMPACT: High
READ TIME: 5 mins
Quality Level Mean [1 – 10]: 9
1. “This installation of Ropes Gray’s podcast series. Non-binding Guidance focuses on FDA regulatory. developments in the area of artificial intelligence. (“AI”) and machine learning.”
2. “In this episode, FDA. regulatory attorneys Kellie Combs, Greg Levine, and Sarah. Blankstein explore the development and uptake of these technologies. in response to the ongoing COVID-19 pandemic, FDA’s current. regulatory landscape for these technologies, recent steps FDA has. taken to update its regulatory approach to these tools in. coordination with industry, and continuing trends in this area they. expect to see through Combs: Hi, I’m Kellie Combs, a. partner in the life sciences and regulatory compliance practice. group at Ropes Gray and co-lead of Ropes Gray’s. Digital Health Initiative.”
3. “As. more and more AI and machine learning tools continue to be. developed, it has become clear that FDA’s current regulatory. framework is not well-equipped to address some of the unique. challenges that these technologies pose.”
4. “The data. might be from diagnostic images or other data sets, and the current. regulatory framework that FDA has is not built to address what. frankly seems like science fiction-medical devices that think for. themselves, that train themselves to establish the initial. algorithm, and then eventually may even adapt over time as they. learn more and more.”
5. “The 2019 discussion paper drew on practices from. existing pre-market programs in the U.S., as well as risk. categorization principles from the International Medical Device. Regulators Forum (or “IMDRF”), other risk-focused FDA. documents on benefit-risk and software modification, and the Total. Product Life Cycle regulatory approach outlined in FDA’s. Digital Health Software Precertification Program (or the. “Pre-Cert Program”).”