Standards, Guidance & Notices
Showing 1–10 of 128
NIST
IR
IR
IR 8259 Rev. 1
Foundational Cybersecurity Activities for IoT Product Manufacturers
Internet of Things (IoT) products often lack product cybersecurity capabilities their customers—organizations and individuals—can use to help mitigate their cybersecurity risks. Manufacturers can help their customers by improving the securability of their IoT products by providing necessary cybersecurity functionality and by providing customers with the cybersecurity-related information they need. This publication describes recommended activities related to cybersecurity that manufacturers should consider performing before their IoT products are sold to customers. These foundational cybersecurity activities can help manufacturers lessen the cybersecurity-related efforts needed by customers, which in turn can reduce the prevalence and severity of compromises.
Published: 2026-04-20
FDA
CDRH
CDRH
fda_20260327_patient_preference_tplc
FDA Issues Final Guidance on Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
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.
Published: 2026-03-27
JFMDA
Notice
Notice
jaame-committee-btoc_report
General Consumer Medical Device Research Committee Report
JFMDA released a report from the General Consumer Medical Device Research Committee on March 23, 2026, addressing the rapidly changing socioeconomic environment and addressing declining birth rates and demographic challenges in the context of medical device accessibility for general consumers.
Published: 2026-03-23
JFMDA
Notice
Notice
committee-Startup_Report
Medical Device Industry Innovation Strategy 2.0: Industry Structure Transformation through Startup Co-creation
On March 17, 2026, JFMDA's Startup Co-creation Promotion Office released the Medical Device Industry Innovation Strategy 2.0, outlining collaborative approaches with startups to drive structural transformation in the medical device industry.
Published: 2026-03-17
FDA
CDRH
CDRH
fda_20260312_weight_loss_premarket
FDA Issues Final Guidance on Medical Devices Indications Associated with Weight Loss - Premarket Considerations
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.
Published: 2026-03-12
FDA
CDRH
CDRH
medical-devices-software-medical-device-samd-artificial-intelligence-enabled-medical-devices
Artificial Intelligence Enabled Medical Devices
FDA CDRH provides regulatory requirements and guidance for medical devices incorporating artificial intelligence (AI) technology. AI-enabled medical devices offer potential benefits including improved diagnostic accuracy and enhanced clinical efficiency; however, algorithm transparency, validation, and continuous monitoring are critical to safe and effective performance. FDA expects manufacturers to conduct machine learning model validation and implement comprehensive risk management strategies. The guidance addresses the unique challenges posed by adaptive algorithms and evolving AI systems in the medical device lifecycle, emphasizing the importance of rigorous testing methodologies and post-market surveillance protocols. Manufacturers must demonstrate that AI systems maintain performance across diverse patient populations and clinical conditions. The document also discusses design controls, software development practices, and documentation requirements specific to AI/ML-based medical devices under 21 CFR Part 820 and FDA premarket submission pathways.
Published: 2026-03-05
FDA
CDRH
CDRH
fda_20260305_digital_health_lists
FDA Updates Lists of Medical Devices that Incorporate Digital Health Technology
FDA has updated its searchable database of medical devices incorporating digital health technology that have received U.S. marketing authorization. The updated lists include AI/ML-enabled Software as a Medical Device (SaMD) products. This reference provides manufacturers and regulators with current visibility into approved digital health and algorithmic medical devices, supporting transparency in regulatory decision-making and market surveillance activities.
Published: 2026-03-05
MHLW
Notice
Notice
MHLW-PSEHB-PSD-0210-No.3
Notice on Partial Revision of 'Reporting of Medical Device Defects and Other Incidents' (Notice 医薬安発0210第3号, February 10, 2026)
Amendment to medical device adverse event reporting requirements, updating procedures for manufacturers and importers to report defects, malfunctions, and serious incidents to PMDA and MHLW in a timely manner.
Published: 2026-02-13
FDA
CDRH
CDRH
FDA-2022-D-0795
Computer Software Assurance for Production and Quality Management System Software
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.
Published: 2026-02-03
ISO
ISO 81001-1 Ed.2
ISO 81001-1 Ed.2 - Health Software and Health IT Systems - Safety, Effectiveness and Security - Part 1: Principles and Concepts
ISO 81001-1 Edition 2 establishes fundamental principles and conceptual frameworks for ensuring safety, effectiveness, and security of health software and health information technology systems. Currently in Committee Draft (CD) stage under ISO/TC 210/WG1, the document is undergoing international standardization review with a voting deadline of March 27, 2026. This standard serves as a foundational framework supporting medical device software regulation globally, providing overarching principles that align with and complement harmonized standards including IEC 62304, ISO 14971, and others. The document addresses the integrated governance of safety, effectiveness, and cybersecurity across the health software lifecycle. Manufacturers should reference this standard to establish consistent quality management approaches and risk governance frameworks applicable to health software and IT systems. Edition 2 reflects evolving regulatory expectations regarding artificial intelligence, machine learning, and connected health technologies in the medical device ecosystem.
Published: 2026-01-30