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...
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...
All definitions in section 201 of the act shall apply to the regulations in this part. (b)投诉Complaint。在设备交付后全部书面、电子或口头,对设备标识、质量、耐用性、可靠性、安全性、有效性和性能方面缺点信息。 (b)Complaintmeans any written, electronic, or oral communication that alleges ...
Definitions (a)法案Act。指明FederalFood,DrugandCosmeticAct,如修正的(secs.201-903, 52Stat.1040etsep.,21U.S.C.321-394)。所有法案section201中的定义在本部分法 规中均适用。 (a)ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(secs.201-903,52Stat. 1040etseq.,asamended(21U.S.C.321-394)...
Learn about the 3 FDA medical device classes. We give comprehensive definitions, examples, and differences of Class I, II, and III devices.
SUBCHAPTERH--MEDICALDEVICES PART820QUALITYSYSTEMREGULATION SubpartA--GeneralProvisions §820.1-Scope. §820.3-Definitions. §820.5-Qualitysystem. SubpartB--QualitySystemRequirements §820.20-Managementresponsibility. §820.22-Qualityaudit. §820.25-Personnel. ...
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 ...
“Medical Device User Fee and Modernization Act of 2002, Establishment of a Public Docket (68 FR 5643)(hereinafter referred to as the MDUFMA Docket). In addition, FDA issued a guidance entitled, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement ...
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 1304 登记者的记录与报告 RECORDS AND REPORTS OF ...
Section3:Definitions 3.0QualityManagementSystemDefinitions ThissectionisfordefinitionsuniquetoColburnManufacturingCompany,Inc. Customerownedproperty-Anytypeofinstrumentation,accessories,manuals,orshipping containersthatbelongtoacustomer. Customersuppliedproduct-Anytypeofserviceormaterialsuppliedtobeutilizedinthe ...