2022 年 2 月 23 日 ,FDA发布如下拟议规则: Medical Devices; Quality System Regulation Amendments,以修订FDA质量体系(QS)法规(21 CFR 820)中器械的当前良好制造实践要求,以纳入ISO 13485:2016的要求,以与ISO 13485的QMS要求趋同,同时继续根据FD&C法案及其实施条例提供同等水平的安全和有效性保证。修订后,QSR820将...
A medical device is any item that is used for the diagnosis, treatment, or prevention of a disease, injury, or other condition and is not a drug or biologic. (See sections 5 and 6 for definitions of terms and concepts.) The user facility reporting section of SMDA became effective on ...
With these definitions, FDA has kept in line with its previous guidance on other health and wellness products, such as mobile medical applications and exercise equipment, where depending on the product's intended use, it could fall under FDA regulations. Under the first category, a manufacturer w...
All definitions in section 201 of the act shall apply to the regulations in this part. (b) 投诉Complaint。在设备交付后所有的书面的、电子的或口头的,对设备的、质量、耐性、、安全性、有效性性能方面的信息。(b)Complaint means any written, electronic, or oral communication that alleges deficiencies ...
“manufacturer” is used in accordance with the definitions of manufacturer in 2 1 CFR Parts 803, 806, 807, and 820 and as described in FDA’s guidance “Policy for Device Software Functions and Mobile Medical Applications” (DSF-MMA) available at /regulatory-information/search-fda- guidance-...
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…
2. Definitions (Proposed § 820.3) FDA建议保留和/或修订当前第820部分中的某些定义。还提议从目前的第820部分中删除某些术语和定义,这些术语和定义在ISO 13485中没有必然结果,因为它们不需要理解和实施拟议的第820部分。从目前的第820部分撤回的定义包括“建立”,即“establish”一词。虽然ISO标准中没有定义建立...
>CDRH参与国际协调和融合工作，包括国际医疗器械监管论坛（IMDRF）发布的最终文件《机器学习医疗器械：关键术语和定义Machine Learning-enabled Medical Devices: Key Terms and Definitions》，并共同主持重启医疗器械 (SaMD)工作组。>2022年10月，CDRH发布“聚焦：数字健康监管科学机遇”重点介绍常见数字健康领域，如患者...
814医疗器械的上市前批准PREMARKETAPPROVALOFMEDICALDEVICES 820质量体系规章QUALITYSYSTEMREGULATION 821医疗器械跟踪要求MEDICALDEVICETRACKINGREQUIREMENTS（只专注于医疗器械领域） 822上市后监视POSTMARKETSURVEILLANCE 860医疗器械分类程序MEDICALDEVICECLASSIFICATIONPROCEDURES 861性能标准制定程序PROCEDURESFORPERFORMANCESTANDARDSDEVELOPMENT...
1300 定义 DEFINITIONS 1301 管制物质的制造者、分销者和调剂者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额 QUOTAS ...