Standards, Guidance & Notices
Showing 1–10 of 129
FDA
CDRH
CDRH
fda_20260630_Clinical_Decision_Support_Soft
Clinical Decision Support Software Frequently Asked Questions Faqs
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.
Published: 2026-06-30
MHLW
Notice
Notice
MHLW-PFSB-MDED-0615-No.1
Notice 薬生機審発0615第1号 (June 15, 2026): Pilot Implementation of Prioritized Review for Software as a Medical Device and Related Products
MHLW announces pilot implementation of prioritized review procedures for Software as a Medical Device (SaMD) and related products under the PMD Act, effective June 15, 2026, to expedite regulatory assessment of innovative software-based medical devices.
Published: 2026-06-25
FDA
CDRH
CDRH
fda_20260625_Notification_on_Data_Integrity
Notification on Data Integrity
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.
Published: 2026-06-25
ISO
ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Guidance on applying the ISO 14971 risk management process to AI/machine-learning-enabled medical devices (MLMD). Covers ML-specific risks such as data management, feature extraction, bias, information security, and training/evaluation of ML models. Intended to be used alongside ISO 14971 and ISO/TR 24971. Does not apply to MLMD employing large language models (LLM) or generative AI.
Published: 2026-06-17
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
EU
MDCG
MDCG
MDCG 2026-4
MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
MDCG 2026-4 — MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use — (June 2026)
Published: 2026-06-01
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