FDA Non-Device Software Functions: Public Input Deadline for 2026 Report

Medical Device Global Market Access · Aug 6, 2026 · 4m

The US FDA has issued a request for public input, due by August 13, 2026, on the risks and benefits of software functions excluded from the medical device definition. This feedback will inform the FDA's 2026 biennial report to Congress on patient safety, potentially shaping the future of digital health regulation for wellness apps, EHRs, and certain clinical decision support tools. This episode covers the background, who is affected, key deadlines, and practical steps for software developers. Key Questions: - What specific types of software are considered "non-device software functions"? -…