This FDA paper addresses key considerations for developing and implementing digitally derived measures in clinical investigations. The document specifies validation requirements, clinical relevance assessment, and alignment with software development standards including IEC 62304. It provides regulatory guidance on demonstrating analytical validity, clinical validity, and utility of digital health technologies used as clinical trial endpoints or outcome measures, supporting FDA's innovation pillar while ensuring patient safety and data integrity.

FDA CDRH, through its Digital Health Center of Excellence, seeks public feedback on regulatory considerations for generative AI-enabled medical devices. The initiative focuses on risk assessment frameworks, premarket evaluation methods, postmarket monitoring strategies, and clinical validation approaches specific to GenAI technologies. This public comment period informs FDA's development of comprehensive regulatory guidance addressing the transformative potential and unique challenges of generative AI in medical device applications, balancing innovation with patient safety.

FDA CDRH has announced selected participants for the TEMPO Digital Health Devices Pilot program. This initiative facilitates collaborative regulatory engagement between FDA and innovative digital health device manufacturers, expediting evaluation pathways while maintaining safety and effectiveness standards. Participants benefit from streamlined premarket review processes, enhanced postmarket monitoring strategies, and real-world evidence generation frameworks, contributing to the development of adaptive regulatory approaches for emerging digital health technologies.

This FDA CDRH guidance document provides recommendations for the content and submission of human factors information in premarket medical device applications including 510(k) and PMA submissions. The guidance specifies required usability engineering documentation based on applicable standards such as IEC 62366-1, risk analysis methodologies, labeling safety considerations, and validation evidence. It establishes expectations for human factors evaluation data components to support FDA's regulatory review of device safety and effective use in intended user populations and use environments.

FDA CDRH provides comprehensive FAQs addressing regulatory classification and oversight of clinical decision support software (CDSS). The guidance clarifies distinctions between software qualifying as a medical device under FDA jurisdiction versus informational tools falling outside regulatory scope. Key topics include risk assessment methodologies, software development and validation requirements aligned with IEC 62304 standards, cybersecurity considerations, and clinical effectiveness evaluation. This reference document serves as essential regulatory interpretation for manufacturers developing CDSS and healthcare IT professionals navigating FDA's evolving software oversight framework.

The FDA CDRH remains vigilant in ensuring the reliability of data submitted in support of medical device submissions. The Agency has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. generated false, copied, or otherwise invalid test data submitted to FDA across multiple studies. Consequently, all study data from this testing facility will be rejected until the firm adequately addresses these data integrity issues. Device manufacturers and sponsors are reminded to conduct rigorous evaluation and oversight of third-party testing facilities to ensure compliance with FDA data integrity standards and Good Laboratory Practice requirements.

FDA CDRH provides regulatory guidance for artificial intelligence-enabled medical devices, addressing the unique oversight considerations for AI/machine learning-based Software as a Medical Device (SaMD). The resource covers quality management systems, validation methodologies, performance monitoring, and cybersecurity requirements aligned with IEC 62304 standards. It serves as a reference document for manufacturers developing AI-integrated medical devices authorized for U.S. marketing, emphasizing transparency, safety evaluation, and ongoing post-market surveillance protocols.

The FDA has updated its comprehensive searchable databases of medical devices incorporating digital health technologies authorized for U.S. marketing. These updated lists encompass artificial intelligence and machine learning-enabled devices, augmented and virtual reality medical devices, and sensor-based digital health technology solutions. This resource provides manufacturers, healthcare professionals, and regulatory stakeholders transparent access to cleared and approved AI/digital health-integrated medical devices, supporting informed decision-making and regulatory compliance efforts while facilitating continued innovation in the digital health medical device sector.

This final guidance document assists sponsors and other stakeholders in collecting, validating, and integrating patient preference information (PPI) to support regulatory decision-making across the complete product lifecycle. The document specifies methodological approaches to study design, data validation, and strategic incorporation of PPI throughout development, premarket review, and post-market phases. A reference document for demonstrating patient-centered evidence in device submissions.

Replaces the September 2023 final guidance. Title updated from "Quality System" to "Quality Management System" reflecting the QMSR final rule (21 CFR Part 820, effective February 2, 2026), which incorporates ISO 13485:2016 by reference. Core requirements for SPDF, premarket cybersecurity documentation, SBOM submission, and CVD policy remain. Adds terminology (Threat surface, Quality of Service) in Appendix 5.