(be provided for any premarket submission that includes device software functions where Enhanced Documentation does not apply.) • Enhanced documentation是要在满足以下四个任一条件时需提供的软件文档: 1) 器械是组合产品的一部分; 2) 器械(a)用于检测献血者是否存在输血传播感染;或(b)用于确定捐赠者和...
2. Software Depending on the proposed indications for use, cardiac monitors may be considered to have a level of concern ranging from minor to moderate. Refer to the “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” for additional information about ...
人因审核优先级最高的器械清单/ Listof Highest Priorities Device for Human Factor Review (draft guidance) 医疗器械软件上市前递交指南/Guidance for the Content of Premarket Submissions for Software Contained in MedicalDevices FDA指南-产品整个生命周期:输液泵上市前通知[510(k)]递交/ Guidance for Industry ...
• Premarket Approval Applications (PMAs) and PMA supplements; （上市批准申请及补充文件）• Produ...
medicaldevicemanufacturerusingOTSSoftwaregenerallygivesupsoftwarelifecyclecontrol, butstillbearstheresponsibilityforthecontinuedsafeandeffectiveperformanceofthemedical device. Thisguidancedocumentisintendedtoprovideinformationregardingtherecommended documentationsponsorsshouldincludeinapremarketsubmissionforFDA’sevaluationofoff- ...
答:预提交Pre-Submission流程为提交者提供了在预期上市前提交(例如510(k) 或 De Novo 分类请求)之前获得 FDA反馈的机会。在预提交中,提交者可以提出与计划的上市前提交相关的问题,例如是否推荐临床研究,或寻求关于临床研究终点、纳入标准和研究打算扩展目前的适应症从仅处方使用到非处方药使用的随访持续时间的反馈。
(三)2023年4月,FDA发布指南草案(Draft Guidance) 2023年4月3日,FDA发布于了《人工智能/机器学习支持设备软件功能的预定变更控制计划的营销提交建议的指南草案(Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software ...
The class and classification of the device impacts what FDA premarket submission or application is required for clearance to market. The common premarketing submission or application for each class are: Note: These are the common regulatory submission and applications for each class of device. There...
docket number FDA-2011-D- 0787. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to dsmica@ to receive an electronic copy of the guidance or...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-preference-information-voluntary-submission-review-premarket-approval-applications Accessed August 2023. Hauber B, Mange B, Zhou M, Chaudhuri S, Benz HL, Caldwell B, et al. Parkinson’s patients’ tolerance for risk ...