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Hi! First, let me say that the following does not constitute legal advice and you should not act or refrain from acting on the basis of the information provided below without first seeking legal advice from counsel. Now on to some thoughts on your question - The short answer is that FDA's ...

Hi Masami, I just took and passed the December 2020 Medical Devices Exam. Please feel free to reach out at josh.a.vanderiet@gmail.com if you want to discuss! I am happy to tell you about how I prepared for the test. Thanks! Josh ------------------------------ Joshua Van De Riet Modi'in ...

Hi Yaara, I might be able to provide some assistance here. Feel free to contact me at josh.a.vanderiet@gmail.com. Thanks! Josh ------------------------------ Joshua Van De Riet Modi'in Israel ------------------------------

Hello All! Just figured I would through this out there again to see if I get any takers! Would appreciate some help in how FDA thinks about clinical trial design for De Novos! Thanks! ------------------------------ Joshua Van De Riet Modi'in Israel ------------------------------

Hi All! This is my first time using the forum so thanks to everyone in advance! I have a client who would like to know if SCED (single case expiremental design) studies with randomized baslines (in this case. a meta analysis of mutlple single case expirmental design trials from different sites) ...