FDA recently issued a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate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...
• Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes • Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities • Reviewer Guidance for N...
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
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...
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...
Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry ENERGY STAR® Requirements for Medical Imaging Equipment Creation of IEC 60601-1 4th Edition IEC TS 60601-4-2 IEC 60601-1-2 Ed. 4.1 Overview of Requirements FDA ASCA Program Q&A Medical OEM Wireless ...
FDA是美国食品和药物管理局(Food and Drug Administration)的简称 ,是美国政府在健康与人类服务部 (DHHS...
Surmodics, Inc. today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB).
The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass performance and function testing, usability, and cybersecurity. This study emphasized the nearly indispensable role of clinical trials in ensuring the clinical effectiveness ...
These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Under theguidance, the AI request must summarize the state...