Explicit UDI labeling guidelines for stand-alone software and SaMD Since FDA issued its draft UDI guidance five years ago, stand-alone medical software / SaMD have become more and more incorporated into healthcare delivery and management systems, requiring FDA and other medical device market regulat...
美国FDA 指导原则 使用来自人体细胞、组织以及细胞和组织产品(HCTPS)供体的身体血液标本获得传染病供体筛查测试标签声明的建议 行业指南 英文原版.pdf,Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Te
Under the510(k) premarket notification process, before a manufacturer can market a medical device of any class in the United States, they must demonstrate to the FDA that it is substantially equivalent (as safe and effective) to a device already on the market. If FDA rules the device is “...
National Medical Products Administration,Beijing 100022, China Abstract: The FDA issued the Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry (Draft) in July 201...
The design review guidelines from 820.30(e) are critical for managing development: Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. Labeling (21 ...
FDA常用指南文件清单 序号中文文件名称原文文件名称1上市前批准申请模块审核Premarket Approval Application Modular Review2医疗器械的电子副本提交程序eCopy Program for Medical Device Submissions3上市前批准…
The article reports on the draft guidance issued by the U.S. Food and Drug Administration (FDA) which informs medical device industry about the intention t... GJ Prud'Homme,KM Zielinski 被引量: 0发表: 2000年 加载更多研究点推荐 Medical Device Patient Labeling ...
适用的FDA法规:软组织超声手术系统可能适用于不同的FDA法规,如医疗器械分类规则(Medical Device Classification Regulations)、医疗器械标记规定(Medical Device Labeling Regulations)等。 510(k)预先市场通知:如果软组织超声手术系统属于预先市场通知(510(k))类别的产品,制造商需要提交510(k)申请,以证明其与已获得FDA批...
本指南提供了骨折固定板的性能标准,以支持基于安全和性能的途径。[1]在此框架下,计划通过骨折固定板的基于安全和性能的途径申请510(k)的申请人(您)可以选择使用本指南中提出的性能标准支持实质等效性,而不是对申报器械的性能与实质等同器械的性能进行直接比较。
21 CFR 807 - 医疗器械注册和清单规定(Medical Device Listing and Registration): 这一章节规定了医疗器械制造商必须向FDA注册其设备,并获得唯一设备标识(Unique Device Identifier,UDI)。这是确保医疗器械追踪和监管的重要步骤。 21 CFR 801 - 标签要求(Labeling Requirements): 医疗器械的标签必须符合FDA的标签要求...