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.

The FDA CDRH issued final guidance on human factors information for medical device marketing submissions, establishing a risk-based framework applicable to 510(k) premarket notifications, De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDEs). The guidance clarifies expectations for human factors documentation, enabling manufacturers to provide appropriately scaled submissions based on device risk. By streamlining requirements, the guidance reduces regulatory burden while maintaining submission quality and ensuring proper risk mitigation in device design and usability.

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.

This final guidance from FDA CDRH provides comprehensive premarket recommendations for medical devices bearing weight loss indications. The document addresses device classification, non-clinical and clinical testing protocols, performance standards, and labeling requirements. Manufacturers should consult this guidance when designing clinical study protocols and compiling premarket submissions to ensure alignment with FDA's current expectations for evidence generation and regulatory documentation.

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.

FDA final guidance (Feb 2026) on risk-based assurance for software used in medical device production and quality management systems. Supersedes the September 24, 2025 version, with the title updated from "Quality System Software" to "Quality Management System Software" to align with the QMSR (21 CFR Part 820 / ISO 13485:2016 harmonization effective February 2, 2026). Replaces Section 6 of the 2002 GPSV. Does NOT apply to SaMD/SiMD.

Final guidance clarifying the regulatory status of Clinical Decision Support (CDS) software under Section 520(o) of the FD&C Act. Defines criteria distinguishing device CDS (subject to FDA oversight) from non-device CDS (exempt). Addresses application to AI/ML-based CDS functions and provides examples across clinical specialties.