Standards, Guidance & Notices
Showing 1–10 of 123
FDA
CDRH
CDRH
medical-devices-software-medical-device-samd-artificial-intelligence-enabled-medical-devices
Artificial Intelligence Enabled Medical Devices
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.
Published: 2026-06-17
FDA
CDRH
CDRH
fda_20260305_digital_health_lists
FDA Updates Lists of Medical Devices that Incorporate Digital Health Technology
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.
Published: 2026-06-17
FDA
CDRH
CDRH
fda_20260528_human_factors
Final guidance for human factors
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.
Published: 2026-05-28
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
EU
MDCG
MDCG
MDCG 2021-24 Rev.1
Guidance on Classification of Medical Devices
Updated guidance on applying the classification rules in Annex VIII of MDR (EU) 2017/745. Clarifies criteria including contact duration, invasiveness, and energy dependence. Applicable to classification of software medical devices including AI/ML-based functions.
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
MHLW
Notice
Notice
Admin-Notice-2026-03-25_SaMDQA3
Q&A Regarding Handling of Medical Device Software (Part 3) (Administrative Notice, March 25, 2024)
MHLW administrative notice providing Q&A guidance on Software as a Medical Device (SaMD) regulatory handling and requirements under the PMD Act.
Published: 2026-03-26
MHLW
Notice
Notice
Admin-Notice-2026-03-19_VPNSecurity
Notice on Strengthening Cybersecurity Measures for Network Devices such as VPN Equipment Connected to Medical Devices (Caution Alert) (Administrative Notice, March 19, 2026)
MHLW caution alert regarding cybersecurity measures for VPN devices and network equipment connected to medical devices, emphasizing the need for strengthened security protocols to protect medical device networks from cyber threats.
Published: 2026-03-25
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
MHLW
Notice
Notice
MHLW-PFSB-MDED-0306-No.1
Notice No. 医薬機審発0306第1号 on Handling of Registration Applications for Registered Conformity Assessment Bodies (March 6, 2026)
MHLW guidance on procedures for registration applications submitted by organizations seeking to become registered conformity assessment bodies under the PMD Act, including application requirements and administrative handling.
Published: 2026-03-06