Standards, Guidance & Notices
Showing 1–10 of 146
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: 2026-08-05
FDA
CDRH
CDRH
fda_20260528_human_factors
Content Human Factors Information Medical Device Marketing Submissions
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.
Published: 2026-08-04
MHLW
Notice
Notice
医薬監麻発0728-No.1
Notice on Applicability to Product Categories of Newly Added General Names (MHLW Medical Device Surveillance Division Notice No. 0728-1, July 28, 2026)
This notice clarifies the applicability of newly added general names to specific product categories under the PMD Act classification system.
Published: 2026-07-30
MHLW
Notice
Notice
医薬薬審発0727-No.11
Handling of Online Submission of Applications and Related Documents (MHLW Notice Nos. 0727-11, 0727-3, 0727-8, 0727-5, July 27, 2026)
This notice establishes procedures and requirements for online submission of pharmaceutical and medical device applications to the MHLW and PMDA.
Published: 2026-07-30
MHLW
Notice
Notice
医薬薬審発0727-No.2
Electronic Payment of Application Fees and Registration License Tax for Pharmaceutical and Medical Device Applications (MHLW Notice Nos. 0727-2, 0727-1, July 27, 2026)
This notice provides guidance on electronic payment methods for application fees and registration license taxes related to pharmaceutical and medical device regulatory submissions.
Published: 2026-07-30
MHLW
Notice
Notice
医薬発0728-No.1
Amendment to Ordinances on High-Risk, Moderate-Risk, and General Medical Devices and Specified Maintenance Management Medical Devices Designated Under PMD Act Articles 2(5)-(8) (MHLW Notice No. 0728-1, July 28, 2026)
This notice announces amendments to the ministerial ordinances specifying classifications of high-risk, moderate-risk, general, and specified maintenance management medical devices under the PMD Act.
Published: 2026-07-28
MHLW
Notice
Notice
医薬発0706-No.1
Amendment to Ordinances on High-Risk, Moderate-Risk, and General Medical Devices and Specified Maintenance Management Medical Devices Designated Under PMD Act Articles 2(5)-(8) (MHLW Notice No. 0706-1, July 6, 2026)
This notice announces amendments to the ministerial ordinances specifying classifications of high-risk, moderate-risk, general, and specified maintenance management medical devices under the PMD Act.
Published: 2026-07-06
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
Pilot Implementation of Prioritized Review for Software as a Medical Device and Related Products (MHLW Notice 薬生機審発0615第1号, June 15, 2026)
This notice announces the trial implementation of prioritized review procedures for Software as a Medical Device (SaMD) and related medical device products under the PMD Act to accelerate market access for innovative digital health technologies.
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