Model: 10ml, 60ml control ring Sterility/Shelf Life灭菌和货架周期 1. You have provided Package Integrity tests and accelerated aging test report summaries. However, the information was unclear, and we were not able to verify that you performed Simulated Distribution testing. As noted in the 2016 ...
Aqueousnon-sterile products, which may support microbial growth during the productshelf life due to their water activity (aw)29, shouldbe designed to prevent microbial proliferation of intrinsic microorganisms orthose inadvertently introduced during use.在产品货架期内由于具备水活性(aw)所以可支持微生物生...
培训内容 1.FDA认证流程及认证文件2.企业注册，510（k）与产品列示3.510（k）Summary介绍4.510（K）查询及产品代码5.设计变更控制6.医疗器械法规监管7.产品labeling的法规符合性8.违规后的处罚及相关事宜9.关于产品进口到美国的信息 3 申请FDA所涉及的法规 CodeofFederalRegulations(CFR)Title21part800-1299Food,...
ThewarningsandprecautionscanbefoundintheElecsysAnti-HBelabeling. V.DEVICEDESCRIPTION TheElecsysAnti-HBeimmunoassayisaqualitativetestthatemploysthe electrochemiluminescence“ECLIA”technology.Theassayemploysatwo-incubation stepassayusingthecompetitionprincipletestformatandatotalassaytimeof18 ...
You should use storage conditions described in the device labeling. You should provide the following information about shelf life: ? ? ? labeled shelf life dates and length of time for each testing interval, e.g., 0, 6 months, 1 year, 2 years resistometer vessel results for each testing ...
shelflife. However, it should be noted that although microorganisms that are presentin a non-sterile drug product with low water activity will not proliferate,they can persist in non-aqueous liquids and dry products throughout ...
Device Description Executive Summary Substantial Equivalence Discussion (Partially Redacted) Summary of Biocompatibility Testing (Partially Redacted) Summary of Sterilization & Shelf-Life (Partially Redacted) Proposed Labeling Predicate Device Labeling Declarations of Conformity (i.e., FDA Form 3654) ...
VOL-013-Proposed Labeling 14) 灭菌和货架寿命:需灭菌要求的,需提供灭菌验证报告,货架寿命验证报告。 VOL-014-Sterilization and Shelf Life 15) 生物相容性:与人体组织接触部件的生物相容性评估及验证报告 VOL-015-Biocompatibility 16) 软件:软件分析验证报告 ...
Labeling 标签与说明书 本章节包括对产品铭牌,说明书,包装彩盒的描述 - 对于家用医疗器械(OTC),FDA要求制造商提供Usability study report 即对产品的使用界面,人机接口, 铭牌说明书做可用性要求, 要求证明普通的美国人群能正确使用该产品。因此Usability study 的报告 29、要对不同教育程度, 美国人种进行试用产品的...
10 Device Description 11 Substantial Equivalence Discussion 12 Proposed Labeling 13 Shelf Life 14 Biocompatibility 15 Software 16 Electromagnetic Compatibility and Electrical Safety 17 Performance Testing – Bench 18 Performance Testing – Animal 19 Performance Testing – Clinical 20 Certification of Compliance...