AI, 513(g)s & FDA Reorganization
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Matt Trachtenberg, former FDA reviewer and current Senior Director of Regulatory Affairs at Tempus AI, to discuss another eventful week in MedTech.
The conversation explores how regulatory teams are beginning to integrate AI into their daily workflows—from monitoring global regulatory changes to building customized regulatory intelligence tools—while highlighting why experienced regulatory professionals remain essential for strategy, critical thinking, and submission quality.
The team also discusses FDA's newest De Novo authorization for Johnson & Johnson's OTTAVA™ Robotic Surgical System, Freenome’s PMA approval for the SimpleScreen™ CRC blood-based colorectal cancer screening test, FDA's first freeze-dried plasma product, and the potential impact of recent FDA organizational restructuring.
Additional topics include:
The future of RAPID and FDA/CMS collaboration
New ISO/DTS 24971-2 guidance for applying ISO 14971 to AI-enabled medical devices
Why 513(g) requests continue to frustrate regulatory professionals
Human factors guidance implementation, updated eSTAR requirements, and key takeaways from the July 22 Town Hall
Updated List of FDA-Authorized Companion Diagnostic Devices (In Vitro and Imaging Tools)
New Guidance: Hemodialysis Blood Tubing Sets for 510(k) Submissions
FDA's modernization of pasteurized orange juice standards
Updated FAQs for bringing radiation-emitting products to market
