ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA finalizes plan to downclassify AI-based skin cancer detections despite cautions from its advisory panel; the EU expands “well-established technologies” list subject to simplified rules; Chile builds out its regulatory framework; AI and digital health news; and more to watch from China, Canada, and Europe.
Top Pick: FDA Bucks Advisors on Melanoma Devices
Agency downgrades AI-based skin detection tools for dermatologists from PMA to 510(k):
FDA moved ahead with plans to downclassify melanoma detection products from Class III to Class II devices despite recommendations against that move from its advisory panel. The agency’s March 24 reclassification order shifts premarket requirements for both optical and electrical impedance melanoma diagnostic devices from PMAs to 510(k)s. It’s a relatively rare example of the agency diverging directly from panel recommendations.
The order aligns with a June 2022 proposal from FDA finding that 510(k)s and “special controls,” including clinical performance testing and postmarket surveillance requirements, are sufficient to mitigate risks such as missed cancers or unnecessary biopsies. The agency subsequently convened its General and Plastic Surgery Devices Advisory Panel, where a majority of the panel members cautioned that downclassification was premature. Panelists questioned whether there was enough information from the two approved devices—Melafind (Strata Skin Sciences), discontinued in 2017 due to low specificity and lack of adoption, and Nevisense (Scibase), which remains on the market—to provide assurances that PMAs weren’t necessary. Some of the external experts also worried that the 510(k) process didn’t provide enough controls to manage updates to the AI algorithms that power the devices’ detection functions.
