Global EditionGovernment & PolicyFDA finalizes AI-enabled medical device life cycle plan guidanceThe agency said it will review developers' modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions.By Andrea FoxDecember 04, 202411:30 AMPhoto: Sarah Silbiger/Getty Images.

Global EditionGovernment&PolicyFDA最终确定了支持人工智能的医疗器械生命周期计划指南该机构表示，它将审查开发商修改的人工智能和机器学习提交的预定变更控制计划，这些计划已经获得批准，而不需要触发新的营销提交。作者：Andrea FoxDecember 04202411:30安菲托：Sarah Silbiger/Getty Images。

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices.

美国食品和药物管理局（FDA）已宣布其关于人工智能医疗设备的最终指南。

The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – aims to provide a 'forward-thinking approach to promote the development of safe and effective AI-enabled devices,' the agency said in a statement Tuesday..

该机构在周二的一份声明中表示，这份文件是针对人工智能设备软件功能的预定变更控制计划的营销提交建议，旨在提供一种“前瞻性思维方法，以促进安全有效的人工智能设备的开发”。。

WHY IT MATTERS

为什么它很重要

The guidance offers recommendations on the information to include in a marketing submission for a device with one or more AI-enabled device software functions. FDA said that for modifications to Artificial Intelligence-Enabled Device Software Functions, or AI-DSFs, which are expected over time, it will not require an entirely new market submission. .

。FDA表示，对于人工智能设备软件功能（AI DSF）的修改，预计随着时间的推移，不需要提交全新的市场申请。。

'Because modifications that are specified and implemented in accordance with an authorized PCCP were reviewed and authorized through the marketing submission containing the PCCP, the modifications can be implemented to the AI-DSF without triggering the need for a new marketing submission,' FDA said in its final guidance posted in the Federal Register. .

FDA在其发布在《联邦公报》上的最终指南中表示：“由于根据授权PCCP指定和实施的修改已通过包含PCCP的营销提交进行了审查和授权，因此可以对AI-DSF实施修改，而无需触发新的营销提交。”。。

Instead, the agency said it will focus modification reviews 'on the aspects of the device that are most significantly modified,' and suggested submitting documents with tracked changes.

相反，该机构表示，将把修改审查的重点放在“设备修改最显著的方面”，并建议提交有跟踪修改的文件。

The agency will host a webinar on January 14, 2025, for industry and others to learn more about the final guidance, according to its announcement.

该机构宣布，该机构将于2025年1月14日举办一次网络研讨会，让业界和其他方面了解更多有关最终指南的信息。

THE LARGER TREND

更大的趋势

The agency has said that while it is committed to deploying new devices faster, it will take a science-based approach to its requirements for medical devices powered by AI and ML.

该机构表示，虽然它致力于更快地部署新设备，但它将采取基于科学的方法来满足人工智能和机器学习对医疗设备的要求。

The agency considered how to avoid multiple submissions for technology expected to evolve and streamline the ongoing regulatory review process for developers across medical device lifecycles.

该机构考虑了如何避免多次提交预期发展的技术，并简化了整个医疗设备生命周期中开发商正在进行的监管审查过程。

The draft guidance considered performance concerning race, ethnicity, disease severity, gender, age and geographical considerations in the ongoing development, validation, implementation, and monitoring of AI/ML-enabled devices, according to Brendan O'Leary, deputy director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health, in the agency's March announcement opening a public comment period..

FDA设备和放射健康中心数字健康卓越中心副主任布伦丹·奥利里（BrendanO'Leary）在3月份发布的公开评论期公告中表示，该指南草案考虑了在人工智能/毫升设备的持续开发，验证，实施和监测中，种族，种族，疾病严重程度，性别，年龄和地理因素的表现。。

ON THE RECORD

记录在案

'The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways,' FDA said on its website.

FDA在其网站上表示：“本指南中的建议适用于人工智能设备，包括通过510（k）、从头和PMA途径审查的设备led组合产品的设备组成部分。”。

'The recommendations in this guidance build on FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.'

“本指南中的建议建立在FDA长期致力于开发和应用创新方法来监管人工智能设备的基础上。”

Andrea Fox is senior editor of Healthcare IT News.

AndreaFox是《医疗保健IT新闻》的高级编辑。

Email: afox@himss.orgHealthcare IT News is a HIMSS Media publication.

电子邮件：afox@himss.orgHealthcareIT News是HIMSS的媒体出版物。

Topics: Artificial Intelligence, Compliance & Legal, Government & Policy, Medical Devices

主题：人工智能、合规与法律、政府与政策、医疗设备

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The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices.

美国食品和药物管理局（FDA）已宣布其关于人工智能医疗设备的最终指南。

The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – aims to provide a 'forward-thinking approach to promote the development of safe and effective AI-enabled devices,' the agency said in a statement Tuesday..

该机构在周二的一份声明中表示，这份文件是针对人工智能设备软件功能的预定变更控制计划的营销提交建议，旨在提供一种“前瞻性思维方法，以促进安全有效的人工智能设备的开发”。。

WHY IT MATTERS

为什么它很重要

The guidance offers recommendations on the information to include in a marketing submission for a device with one or more AI-enabled device software functions. FDA said that for modifications to Artificial Intelligence-Enabled Device Software Functions, or AI-DSFs, which are expected over time, it will not require an entirely new market submission. .

。FDA表示，对于人工智能设备软件功能（AI DSF）的修改，预计随着时间的推移，不需要提交全新的市场申请。。

'Because modifications that are specified and implemented in accordance with an authorized PCCP were reviewed and authorized through the marketing submission containing the PCCP, the modifications can be implemented to the AI-DSF without triggering the need for a new marketing submission,' FDA said in its final guidance posted in the Federal Register. .

FDA在其发布在《联邦公报》上的最终指南中表示：“由于根据授权PCCP指定和实施的修改已通过包含PCCP的营销提交进行了审查和授权，因此可以对AI-DSF实施修改，而无需触发新的营销提交。”。。

Instead, the agency said it will focus modification reviews 'on the aspects of the device that are most significantly modified,' and suggested submitting documents with tracked changes.

相反，该机构表示，将把修改审查的重点放在“设备修改最显著的方面”，并建议提交有跟踪修改的文件。

The agency will host a webinar on January 14, 2025, for industry and others to learn more about the final guidance, according to its announcement.

该机构宣布，该机构将于2025年1月14日举办一次网络研讨会，让业界和其他方面了解更多有关最终指南的信息。

THE LARGER TREND

更大的趋势

The agency has said that while it is committed to deploying new devices faster, it will take a science-based approach to its requirements for medical devices powered by AI and ML.

该机构表示，虽然它致力于更快地部署新设备，但它将采取基于科学的方法来满足人工智能和机器学习对医疗设备的要求。

The agency considered how to avoid multiple submissions for technology expected to evolve and streamline the ongoing regulatory review process for developers across medical device lifecycles.

该机构考虑了如何避免多次提交预期发展的技术，并简化了整个医疗设备生命周期中开发商正在进行的监管审查过程。

The draft guidance considered performance concerning race, ethnicity, disease severity, gender, age and geographical considerations in the ongoing development, validation, implementation, and monitoring of AI/ML-enabled devices, according to Brendan O'Leary, deputy director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health, in the agency's March announcement opening a public comment period..

FDA设备和放射健康中心数字健康卓越中心副主任布伦丹·奥利里（BrendanO'Leary）在3月份发布的公开评论期公告中表示，该指南草案考虑了在人工智能/毫升设备的持续开发，验证，实施和监测中，种族，种族，疾病严重程度，性别，年龄和地理因素的表现。。

ON THE RECORD

记录在案

'The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways,' FDA said on its website.

FDA在其网站上表示：“本指南中的建议适用于人工智能设备，包括通过510（k）、从头和PMA途径审查的设备led组合产品的设备组成部分。”。

'The recommendations in this guidance build on FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.'

“本指南中的建议建立在FDA长期致力于开发和应用创新方法来监管人工智能设备的基础上。”

Andrea Fox is senior editor of Healthcare IT News.

AndreaFox是《医疗保健IT新闻》的高级编辑。

Email: afox@himss.orgHealthcare IT News is a HIMSS Media publication.

电子邮件：afox@himss.orgHealthcareIT News是HIMSS的媒体出版物。