The FDA updated its Clinical Decision Support (CDS) Software guidance in January 2026, reshaping how developers and healthcare providers approach digital health tools. This update clarifies which CDS software functions are excluded from FDA regulation under the 21st Century Cures Act and which still require oversight. Understanding these changes is crucial for anyone involved in developing, deploying, or using clinical decision support tools. What the Revised Guidance Covers

The FDA updated its General Wellness policy in January 2026, offering clearer guidance on how it regulates low-risk wellness products. This update affects manufacturers and developers of consumer wellness devices and software designed to promote healthy lifestyles without diagnosing or treating diseases. Understanding these changes is crucial for companies to avoid unnecessary regulatory burdens and for consumers to know what products fall under FDA oversight. FDA's updated p

Artificial intelligence (AI) is transforming healthcare, especially through AI-enabled medical devices that learn and improve over time. But this rapid evolution poses a challenge for regulators who must ensure these devices remain safe and effective as they change. To address this, the U.S. Food and Drug Administration (FDA) introduced the Predetermined Change Control Plan (PCCP) guidance, finalized in August 2025. This guidance offers a clear path for manufacturers to propo

The European Union’s Artificial Intelligence Act, adopted in 2024, marks a significant step in regulating AI technologies across member states. For medical device manufacturers, this new regulation introduces important requirements that intersect with existing rules under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Understanding how these frameworks work together is essential for companies developing AI-enabled medical devices to ensure com

The FDA’s updated Quality Management System Regulation (QMSR), effective in 2026, introduces significant changes that medical device manufacturers must understand and implement. These changes affect how companies manage quality systems, align with international standards, and prepare for inspections. This post breaks down the practical implications of the updated QMSR, focusing on mapping to ISO 13485:2016, integrating risk management, adapting to the new inspection program,

The Medical Device Single Audit Program (MDSAP) plays a critical role in how medical device manufacturers meet regulatory requirements across multiple countries. On February 2, 2026, the MDSAP audit approach underwent a significant revision, with the official update dated February 6, 2026. This change aligns the audit process more closely with the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR). Understanding these updates is essential fo

Clinical Decision Support (CDS) software plays a critical role in healthcare by assisting clinicians in making informed decisions. As regulatory landscapes evolve, understanding which CDS functions fall under medical device regulations and which qualify as non-device CDS is essential. The year 2026 brings new clarity on regulatory boundaries, especially with the intersection of FDA and EU digital health policies and Quality Management System Regulation (QMSR) expectations. Th

The European Database on Medical Devices (EUDAMED) will become mandatory for certain modules starting May 28, 2026. This change requires manufacturers, authorized representatives, and Notified Bodies to prepare thoroughly for actor, UDI, and device registration. Ensuring data quality and timely submissions will be critical to compliance and market access. This post guides you through the essential steps to master EUDAMED go-live readiness, including data cleansing, system int

Health Canada has introduced significant changes to the Medical Device Licence (MDL) application process, effective February 2, 2026. These updates come with the release of version 5 of the Guidance on Managing Applications for Medical Device Licences, published on November 21, 2025. The new guidance replaces the 2020 version and brings stricter timelines, enhanced screening procedures, and a revised reconsideration process. For manufacturers and stakeholders in the medical d