This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA colleague and regulatory expert Dulciana Chan to unpack another busy week across medical devices, diagnostics, and FDA policy.

The conversation covers FDA's newest De Novo authorization for an augmented reality surgical navigation platform, AI-powered diagnostic software receiving Breakthrough Device Designation, and why one ADHD digital therapeutic caught the panel's attention.

The group also takes a deep dive into the FDA's third-party review program, small business fee waivers, FDA recruitment, biocompatibility town halls, non-device software function reporting, why 513(g) requests still aren't anyone's favorite pathway, and whether the Humanitarian Device Exemption (HDE) pathway still works as intended.

Links

• Third Party 510(k) Program: Performance Metrics and Q2 2026 Report

• Small Business Designation (SBD) deadlines

• The FDA Public Health Pillars

• Presentation, Slides, and Transcript from the READI-Home Innovation Challenge Webinar

• Upcoming FDA biocompatibility town halls

  • Biocompatibility Risk Assessment (9/9/26, 1-2pm ET)

  • Biocompatibility and Chemical Characterization Testing – Extractions (9/23/26, 1-2pm ET)

  • Biocompatibility and Toxicological Risk Assessment (10/7/26, 1-2pm ET)