US FDA Regulation of Human Cell and Tissue Products
有任何问题？向我们的专家获取相关信息
联系我们
Does your medical device contain animal or donated human cells or tissues? If so, you must meet complex regulations before you can market your device in the United States.
US Food and Drug Administration regulations for such devices, commonly referred to as HCT/Ps (Human Cells, Tissues, and cellular and tissue-based Products), are daunting and any misstep in the regulatory process can be costly and delay the clearance of your device. In this whitepaper, we'll answer your biggest questions regulatory issues specific to HCT/Ps, including:
- What is a HCT/P?
- How does the US FDA regulate HCT/Ps?
- How are HCT/Ps classified by the FDA?
- What is Tissue Bank Establishment registration?
About the Author
Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey’s areas of expertise include US FDA medical device registration as well as European and Canadian device registration.
相关
-
韩国医疗器械法规框架及注册路径解读
我们的专家将详细解读2023年韩国食品药品安全部（MFDS）指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范（KGMP）等相关要求，并将依据多年韩国本地注册经验提供注册案例分享。此外，您还将了解到制造商在面对MFDS监管时需要关注的核心要点，相关研讨会内容包括：
阅读更多 -
韩国医疗器械注册
阅读更多