ARTICLE SUMMARY:
In this week’s Pathways Picks: Australia issues two items navigating the borderlines of medical device regulations for digital health products; UK recommends AI tools for prostate cancer; FDA advances eSubmissions efforts for investigational device exemptions; China publishes transcatheter tricuspid valve guidance; and more from the US, Brazil, and South Korea.
Editor’s note: There will be no Pathways Picks published November 4. Look for the next edition on November 11. In the meantime, check MyStrategist.com for more coverage of global medtech regulations and policy.
Digital Health Picks
Aussies discern digital regs
Australia’s Therapeutic Goods Administration (TGA) issued two recent items navigating the borderlines of medical device regulations for digital health products.
On October 16, TGA published the outcomes of its review of so-called digital scribes—software tools, increasingly incorporating AI, deployed to support clinical documentation and reduce administrative burden. TGA found multiple examples of digital scribes not identified as medical devices but displaying functions that appear to meet the definition of a device. In response to the review, the agency says it will “conduct proportional compliance.” It also cited guidance available to help manufacturers understand when the regulations apply.
Separately, on October 26, TGA issued a consultation on digital mental health tools (DMHT) seeking feedback on its plan to consider changing or getting rid of regulatory exemptions for DMHTs in light of increasing complexity and use of AI. DMHTs are currently exempted if they are based on established clinical practice guidelines in a manner reviewable by the user. “However, these criteria do not account for a product’s intended purpose, user groups, output types, clinical claims or the consequences if it doesn’t work as intended,” the consultation states. The agency wants input in support of either making no changes, removing the exemptions outright, or retaining them only for very low-risk DMHTs, with comments due December 7.
