While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function. The international medical device regulators forum (IMDRF), of which the US FDA is a member, describes SaMD as software that may work on general-...
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 (SaMD) guidance）目的一致。截至2017年底，FDA已初步完成了一些“数字健康创新计划”中比较重要的工作。其中，“临床和患者决策支持软件”指导原则草稿、“21世纪治疗法案3060章导致的已...
Top Takeaways from FDA Draft Guidance on Software as a Medical DeviceMichele L. BuenafeM. Elizabeth Bierman
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 (SaMD) guidance)目的一致。 截至2017年底,FDA已初步完成了一些“数字健康创新计划”中比较重要的工作。其中,“临床和患者决策支持软件”指导原则草稿、“21世纪治疗法案3060章导致的已有...
研究点推荐 FDA Draft Guidance Software as a Medical Device 站内活动 0关于我们 百度学术集成海量学术资源,融合人工智能、深度学习、大数据分析等技术,为科研工作者提供全面快捷的学术服务。在这里我们保持学习的态度,不忘初心,砥砺前行。了解更多>> 友情链接 ...
Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff Document issued on December 8, 2017. The draft of this document was issued on October 14, 2016. For questions about this document, contact the Office of the Center Director at...
On Jan. 7, 2025, the FDA issued itsdraft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should...
FDAstafforOfficeresponsibleforthisguidanceaslistedonthetitlepage. I.Introduction Off-the-shelf(OTS)Softwareiscommonlybeingconsideredforincorporationintomedical devicesastheuseofgeneral-purposecomputerhardwarebecomesmoreprevalent.Theuseof OTSSoftwareinamedicaldeviceallowsthemanufacturertoconcentrateontheapplication ...
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 as traditional medical ...
In December, FDA issued two draft guidances, Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, meant to clarify the agency’s role ...