US FDA Regulations for Novel and Innovative Products
有任何问题？向我们的专家获取相关信息
联系我们
Ready to sell your novel device in the United States? In a system based on predicate devices and substantial equivalence, marketing an innovative or novel device comes with some unique challenges. What do you do when your innovative device has no predicate?
As the range of novel and innovative medical devices continues to grow, the challenge for both industry and the US FDA is to determine the best way to get these new devices to health care providers and patients as soon as possible, while ensuring safety and effectiveness. In this whitepaper, we discuss your options for bringing your novel device to the US market.
What you will learn in this 7-page white paper:
- What are the common regulatory pathways in the US?
- What does novel mean?
- What to do if your device is truly novel?
- What is the de novo process?
- What is humanitarian device exemption (HDE)?
- What is the expedited access pathway (EAP)?
Get answers to all of these questions and more in this white paper.
About the Author
Audrey Swearingen, RAC (US): 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
-
美国FDA eSTAR电子递交模板与资源要求解析
自2018年起，美国食品和药物管理局（U.S. Food and Drug Administration，FDA）开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年，为推进以电子格式提供510(k)递交文件的过渡，美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多 -
澳大利亚TGA认证和医疗器械注册审批流程
为了获得澳大利亚市场准入，医疗器械和体外诊断（IVD）器械制造商需要将他们的产品列入由药品管理局（TGA）监管的澳大利亚医疗用品登记表（ARTG）。
阅读更多