FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical DeviceNeha K. Patel
One revolutionary development in digital health technology is software that can perform complex medical functions— software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management. Back to top Reimagining digital health regulation: An agile model ...
2017年7月，FDA发布了“数字健康创新计划”（Digital Health Innovation Action Plan, DHIAP ），包括颁布新法规实施相关的指导原则、重构数字健康产品监管体系和增长专业知识三个方面。其中阐述了对于确保高质量、安全和有效的数字医疗的指示，并宣布该计划与《作为医疗器械的软件指南》（Software as a Medical Device (...
In an important move, the U.S. Food And Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on devices like the iPhone and Android mobile devices. Some applications, it said, will be treated with the same scrutiny ...
2021.11.04,FDA官网发布器械软件功能递交文档草稿指南,即,Content of Premarket Submissions for Device Software Functions,以替代2005年发布的指南Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,主要是为了更新FDA关于审核上市前递交文档中软件功能的想法。 此草稿指南,主要...
FDAstafforOfficeresponsibleforthisguidanceaslistedonthetitlepage. I.Introduction Off-the-shelf(OTS)Softwareiscommonlybeingconsideredforincorporationintomedical devicesastheuseofgeneral-purposecomputerhardwarebecomesmoreprevalent.Theuseof OTSSoftwareinamedicaldeviceallowsthemanufacturertoconcentrateontheapplication ...
After receiving over 1,800 comments in response to the initial draft, the Food and Drug Administration (FDA) released final cybersecurity guidance for medical devices that applies to devices with cybersecurity considerations, particularly those with a device software function or devices that contain so...
根据美国FDA的定义,医疗器械软件(Software as a Medical Device, SaMD)是指任何符合医疗器械法律定义的软件,包括一个或多个软件组件、部件、附件或仅由软件组成的器械。 国际医疗器械监管机构论坛(International Medical Device Regulators Forum,IMDRF)将医疗器械软件定义为:拟用于一个或多个医疗目的的软件,在执行这些...
"This guidance recommends that a PCCP describe the planned [AI-enabled device software function] modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing...
We recently blogged on FDA’s draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing. We noted tha...