ARTICLE SUMMARY:
MDFS announces its variation on staged approvals for AI. Excerpted from Pathways Picks September 16: TAVR Coverage, New AI Routes, Harmonization Actions, and More.
South Korea’s Ministry of Food and Drug Safety advanced its own novel premarket framework for AI devices, along with other policy announcements this week to support oversight of advanced software tools under its Digital Medical Products Act:
Component-by-component evaluations. MFDS announced it is establishing a different variation on a staged approval framework than what MHRA laid out. Under an approach described in September 16 guidelines, the agency says it will evaluate key components of a system, for instance a biosensor or the AI algorithm, as distinct elements in advance of a submission for the full system. “Manufacturers can then apply for digital medical device authorization using components that have already passed this pre-evaluation,” MFDS explains. The agency says it hopes the approach will reduce development costs and shorten time-to-market.
Clinical protocols parsed. On September 10, meanwhile, MFDS updated its guidelines outlining clinical trial protocols for seven indications of digital therapeutics. The revisions aim to “reduce trial-and-error for developers and shorten clinical trial preparation time by presenting practical review criteria that reflect actual review cases and the latest international trends,” the agency stated in reference to the new protocols for digital tools seeking therapeutic labeling for nicotine use disorder, alcohol use disorder, panic disorder, depressive disorder, eating disorder, attention deficit hyperactivity disorder, and mild cognitive impairment.
GMP basics. On the same day but in a separate forum, the agency explained its expectations for good manufacturing practice (GMP) compliance for digital medical devices in a comprehensive Q&A guidance document published September 10. South Korea’s Digital Medical Products Act took effect last year, establishing a distinct set of rules, including GMPs, for medical device software, AI-enabled tools, robotics, and other digital tools.
The Q&A spells out documentation requirements, on-site and virtual audit procedures, and compliance questions specific to digital health products, such as addressing circumstances when software and hardware are produced at different facilities and details for verifying performance of AI models in the context of GMP audits. It also explains that companies with established GMP certifications under South Korea’s medical device and IVD regulations will need to undergo a distinct audit to cover digital product manufacturing, but in some cases can benefit from an “alternative” streamlined process leveraging overlap between the regulatory frameworks.