ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA publishes more than 31 guidance documents in one day, including drafts addressing AI devices, pulse oximeters, gender-specific study data, emergency diagnostics, and more; the agency reports that companies are starting to voluntarily submit diversity action plans for clinical studies, and it unveils a virtual reality tool to support home device development; also regulatory updates from China, Thailand, India, Brazil, Australia, and Canada.
FDA Guidance Bonanza
A busy publishing day for the agency:
FDA issued 31 draft and final guidance documents in one day, January 6. The treasure trove of guidelines comes just two weeks before the current HHS/FDA leadership exits and the Trump administration takes power. Several of the documents in particular should be on device companies’ radar:
67 pages on AI. FDA published a major draft guidance (public comments due April 7) on “Lifecycle Management and Market Submission Requirements” for AI-enabled devices. It will complement the recently finalized guidance on the use of “predetermined change control plans” for AI/ML devices, providing more comprehensive recommendations on design, development, maintenance and documentation requirements for these software-based products. On the same day, FDA published a separate draft guidance with recommendation on using AI to support drug and biologic development.
Pulse oximeter for all skin pigments? The agency published a hotly anticipated draft guidance (comments due March 10) on pulse oximeters, specifically to lay out new recommendations for manufacturers to evaluate their devices across the range of skin pigmentation. The draft comes following years of discussion, including multiple FDA advisory panel meetings about data showing less accurate results for oximeter for patients with darker skin. For pulse oximeters on the market that can meet the updated performance criteria without significant modifications, FDA says it will review updates labeling referencing clinical data across skin pigmentations within 30 days of submission.
