2024年9月19日, FDA 发布重磅指南草案——Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff(用于医疗器械生物兼容性评估的化学表征),该指导文件草案提供了FDA关于化学表征测试的建议,以评估医疗器械的生物相容性。同时鼓励制造商...
In September 2024, the FDA issued the Draft Guidance "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry". In this document, the FDA provides recommendations for analytical chemistry testing to evaluate the biocompatibility of medical devices or a device ...
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...
Implant Device: Blood (2) 接触时长: Limited: Less than or equal to 24 hours Prolonged: Greater than 24 hours to 30 days Long-term/Permanent: More than 30 days 每个类型需要做的具体生物相容测试请详见FDA’s Biocompatibility Guidanceon Use of ISO 10993-1 ...
FDA recently issued a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate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...
We recently blogged on FDA’s draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate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. We noted tha...
How do you clean it? How do you remove the processing agents form the final product? How do you ensure biocompatibility? But, as Pollack said, “they’re not showstoppers, just questions.” And if you’re unwilling to take the agency at its word, consider the experience of Stryker, which...
“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 Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk ...
Draft Guidance Topics • Chemical Analysis for Biocompatibility Assessment of Medical Devices 医疗器械生物相容性评价之化学分析 • Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 关于人工智能/机器学习(AI/...
MFDS accepts the majority of the standards acknowledged by the U.S. FDA. The information supplied by such foreign test reports is essential. For instance, foreign test reports on electrical safety or EMC need to be prepared in the form of CB scheme. Biocompatibility test reports should mention...