导读:2024年9月19日, FDA 发布重磅指南草案用于医疗器械生物兼容性评估的化学表征,该指导文件草案提供了FDA关于化学表征测试的建议,以评估医疗器械的生物相容性。 2024年9月19日, FDA 发布重磅指南草案——Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and——官方链接 一 指南更新概述 此次指南的更新是根据2020年《Select Updates for Biocompatibility of Certain Devices in Contact with Intact...
Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological ...
FDA recently issued a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing. Chemical characterization...
指南详情可以参考以下网址:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemical-analysis-biocompatibility-assessment-medical-devices?utm_medium=email&utm_source=govdelivery
二、食品FDA注册流程是什么?（1）咨询---申请人提供产品资料图片或通过描述说明所需要申请FDA的产品；（...
19有关使用TTC和构效关系(SAR)模型在风险管理过程中解决遗传毒性和致癌性问题的信息,请参见ICH M7《评价和控制药物中DNA反应(诱变)杂质以限制潜在致癌风险》,可登录以下网址获取/regulatory-information/search-fda-guidance-documents/m7r1-assessment-and- control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit...
The guidance specifically addresses ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” Key components of the new FDA biocompatibility guidance Major elements of the updated final guidance on ISO 10993-1 include the foll...
The U.S. Food & Drug Administration (FDA) has been releasing new policies and guidance documents on a nearly daily basis.
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)16 此节要求仪器等效比需要另外再单独描述, ,要注意把关键的参数进行比对描述, 如光功率密度,存储环境,输出波形,脉冲宽度,电压等.,如何准备510K 申请文件,FDA 510K Screen checklist 要求的申请文档或报告(8): Biocompatibility 生物...