Fireside Chat: Adapting to FDA & CDRH Changes: What’s Ahead for Software-Driven Devices
Time: 12:30 pm
day: Conference Day One Morning
Details:
- How internal restructuring and funding pressures at the FDA/CDRH may affect review timelines, submission predictability, and early engagement (e.g. pre-subs)
- Preparing for increased reviewer turnover – and what it means for continuity, communication, and expectations across the submission lifecycle
- Best practices for clearly documenting architecture, validation, and risk for AI/ML and connected devices – to minimize friction and rework during review
- Strategies to ensure alignment between software, regulatory, and quality teams in an environment of tighter resources and shifting FDA priorities