Standards, Guidance & Notices
Showing 41–50 of 134
IMDRF
IMDRF/SaMD WG/N81 FINAL:2025
Characterization Considerations for Medical Device Software and Software-Specific Risk
Final document of the IMDRF SaMD Working Group that supplements the N12 SaMD risk categorization framework and broadens its scope to all medical device software, including software that is part of a hardware medical device. It identifies key elements of an intended use/intended purpose statement and organizes characterization features and attributes into four groupings: medical problem and/or objective, context of use, function and/or use (e.g., output type, input source, degree of autonomy, explainability), and change management. For risk characterization, it focuses on information-related (performance-related) hazards, considers both direct and indirect harms including reduction of effectiveness, and notes that it can be helpful to set the probability of software failure to 1 when estimating software-specific risk. Appendices provide guiding questions and worked examples. The document is not regulation or guidance, does not provide guidance on device classification, and does not replace N12 or risk management standards such as ISO 14971.
Published: 2025-01-29
IMDRF
IMDRF/AIML WG/N88 FINAL:2025
Good machine learning practice for medical device development: Guiding principles
Final document of the IMDRF AI/ML-enabled Working Group setting out 10 guiding principles for Good Machine Learning Practice (GMLP), intended to promote the development of safe, effective, and high-quality AI-enabled medical devices across the total product life cycle. The principles cover: understanding the intended use and leveraging multidisciplinary expertise; good software engineering, medical device design, and security practices; clinical evaluation using datasets representative of the intended patient population; independence of training and test datasets; fit-for-purpose reference standards; model choice and design tailored to the available data and intended use; assessment focused on human-AI interactions and the performance of the human-AI team rather than the device in isolation; testing under clinically relevant conditions; clear, essential information for users; and monitoring of deployed models and management of re-training risks. The document presents the principles as a call to action for standards organizations, regulators, and other bodies to further advance GMLP, and notes that generative AI may heighten their importance.
Published: 2025-01-29
FDA
CDRH
CDRH
FDA-AI-DSF-Draft-2025
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
FDA draft guidance (January 2025) on lifecycle management and marketing submissions for AI/ML-enabled SaMD. It provides specific recommendations on training data management, performance monitoring, and change management (PCCP: Predetermined Change Control Plan), including recommendations on handling adaptive algorithms and on describing postmarket performance monitoring plans. Still at the draft stage, pending finalization.
Published: 2025-01-07
ISO
ISO/TS 81001-2-1:2025
Health software and health IT systems safety, effectiveness and security — Part 2-1: Coordination — Guidance and requirements for the use of assurance cases for safety and security
Establishes requirements and guidance on assurance case framework for healthcare delivery organizations and health software manufacturers.
Published: 2025-01-01
JFMDA
Notice
Notice
jfmda_20241226_146b6000
Guidance for Companies on the Development of AI Medical Devices Using Pseudonymously Processed Information, Version 1.0
On December 25, 2024, Team 1 of the JFMDA Subcommittee on Handling of Personal Information compiled and published the "Guidance for Companies on the Development of AI Medical Devices Using Pseudonymously Processed Information, Version 1.0." On the same date, the Medical Device Evaluation Division of the MHLW Pharmaceutical Safety Bureau issued an administrative notice providing information on the guidance. As explained in Chapter 0 (Background and Purpose) of the guidance, developing AI-enabled medical devices generally requires large volumes of medical data, such as clinical information, images (CT, MRI, etc.), and other non-text information (ECG, EEG, etc.). However, medical information held by medical institutions generally constitutes personal data under the Act on the Protection of Personal Information, and it is usually not collected for the purpose of AI medical device research and development.
Published: 2024-12-26
FDA
CDRH
CDRH
FDA-PCCP-AI-DSF-2024
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA final guidance (December 2024) on Predetermined Change Control Plans (PCCPs), which streamline change management for AI-enabled medical devices. Modifications described in an authorized PCCP can be implemented without a new premarket submission for each change. It specifies the three elements a PCCP should include: a description of modifications, a modification protocol, and an impact assessment. It puts into practice the statutory framework of section 515C of the FD&C Act, added by FDORA.
Published: 2024-12-04
NIST
SP
SP
SP 800-161 Rev. 1
Cybersecurity Supply Chain Risk Management Practices for Systems and Organizations
Organizations are concerned about the risks associated with products and services that may potentially contain malicious functionality, are counterfeit, or are vulnerable due to poor manufacturing and development practices within the supply chain. These risks are associated with an enterprise’s decreased visibility into and understanding of how the technology they acquire is developed, integrated, and deployed or the processes, procedures, standards, and practices used to ensure the security, resilience, reliability, safety, integrity, and quality of the products and services.
This publication provides guidance to organizations on identifying, assessing, and mitigating cybersecurity risks throughout the supply chain at all levels of their organizations. The publication integrates cybersecurity supply chain risk management (C-SCRM) into risk management activities by applying a multilevel, C-SCRM-specific approach, including guidance on the development of C-SCRM strategy implementation
Published: 2024-11-01
EU
MDCG
MDCG
MDCG 2024-11
Guidance on qualification of in vitro diagnostic medical devices
Guidance (MDCG 2024-11, published October 2024) on how to determine whether a product qualifies as an in vitro diagnostic medical device (IVD) or IVD accessory under the IVDR (Regulation (EU) 2017/746). It sets out the general principle that qualification depends on the intended purpose given by the manufacturer, as indicated on labelling or in promotional material, and applies the definitions in Article 2(2) and 2(4) of the IVDR. The guidance provides a non-exhaustive set of examples to help distinguish IVDs from borderline cases, including devices falling under the MDR, non-medical products such as ancestry or lifestyle tests, and tests used to monitor the manufacturing of other products such as pharmaceuticals, and recommends using it alongside the Manual on borderline and classification.
Published: 2024-10-01
EU
MDCG
MDCG
MDCG 2022-5 rev.1
Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
Revision 1 of MDCG 2022-5 (published 29 October 2024), guidance on the borderline between medical devices and medicinal products under the MDR (Regulation (EU) 2017/745). It covers the core concepts for making this distinction, including the definitions of pharmacological, immunological and metabolic means of action, the treatment of plant-based or herbal substances (to which the same principles as conventional medicinal substances apply), substance-based medical devices (where Rules 3 and 21 are relevant), and combination products of medical devices and medicinal products, illustrated with a flowchart of regulatory outcomes for different scenarios. It confirms that a product containing a medicinal substance can still qualify as a medical device where that substance plays an ancillary role and the principal intended effect is not achieved by pharmacological, immunological or metabolic means. Revision 1 adds new text on products intended solely for cleaning, disinfection or sterilization, clarifying that single-purpose products of this kind are medical devices, while multi-purpose disinfectants fall under the Biocidal Products Regulation (EU) No 528/2012.
Published: 2024-10-01
JFMDA
Notice
Notice
jfmda_20240924_7f46b062
SaMD Rebalance Notification (Staged Approval) Case Study Collection (Disease Diagnosis SaMD)
Case study collection (published 24 September 2024) prepared by the Japan Federation of Medical Devices Associations (JFMDA, Task Force on the Two-Stage Approval System, Program Medical Device Regulatory Response SWG), building on discussions with the Japan Digital Health Alliance (JaDHA), to promote understanding and appropriate use of the SaMD Rebalance Notification (the notice of 16 November 2023 on the handling of two-stage approval reflecting the characteristics of program medical devices). It covers disease-diagnosis SaMD, the companion volume to a treatment-use version published by JaDHA. The two-stage approval scheme mainly targets SaMD, such as programs that calculate physiological parameters from non-invasive measurements or imaging, that provide reference information whose clinical significance is not yet established; it excludes products where an incorrect result could seriously affect human life or health. The collection presents both applicable and non-applicable examples, intended as a reference for SaMD developers, including venture and IT companies, when planning development strategy and for discussions with regulatory authorities.
Published: 2024-09-24