Stop being paralyzed by the FDA scare and get your medical device to the U.S. market [part 2].  

This is the second part of our short informational series on FDA procedures for approval of medical devices. In our previous post we have analyzed what makes your product a medical device and its three possible classifications depending its type and application. Below we cover the most confusing and at the same time interesting part, i.e. the consequences of being assigned to one of the three classes and the resulting formalities you will need to take care of. The applicable standards in the context of the market entry. Class I The most lenient standard applies in this case. Apart from few particular products, most of the devices in this class are exempt from any premarket notification or approval requirements. Remember…

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Stop being paralyzed by the FDA scare and get your medical device to the U.S. market [part 1]

One of the most problematic issues for the med-tech startups is what to do in order to legally access the fertile U.S. market, i.e. how to obtain the Food and Drug Administrations’ (FDA) approval for their product. This problem seems to be overwhelming some of our European clients what slows down their businesses and hinders the American healthcare. Because we care about both we have decided to write this short series of two informational blog posts. Ok, so you have a product and you want to bring it to the American market. What now? There are two main questions you need to answer, firstly, whether your product is indeed a medical device and, secondly, how it is classified by the…

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