Episode Details

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"? - Why did the FDA issue this request for comments on July 14, 2026? - What is the significance of the August 13, 2026 comment deadline? - How will this feedback influence the FDA's 2026 report to Congress? - Could this process lead to new regulations for health and wellness apps in the future? - What are the key differences between regulated Software as a Medical Device (SaMD) and non-device software? - What practical steps should digital health companies take in response to this request? Sources: - https://www.medicaldevice-network.com/news-archive/medical-device-news-13-19-july-2026-mdn-011/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies navigating complex global requirements. Our experts can help you determine the regulatory classification of your software in the US and over 30 other markets, develop a clear market access strategy, and prepare technical documentation for submission. By combining local expertise with advanced AI, we streamline the process of achieving and maintaining compliance, allowing you to bring innovative products to patients faster. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI tools and global device database at https://pureglobal.ai.