Startup medical device companies are always coming up with new innovative technology. The challenge is, when you search for a predicate to get a 510(k) from the FDA, you can't find a device with the same indication for use and the same technological characteristics. We're going to show you how on July 18th.
We're hosting a webinar on how to identify a potential predicate we've done this before but now we have a template that walks you step by step exactly through what we do. It shows you screen captures and gives you examples of exactly what we use in the FDA database and other proprietary databases to identify a predicate. You need this because you have to document your efforts to identify a predicate if you're going after a De Novo, because your device is so Innovative it doesn't qualify for a 510(k). You have to identify the classification, justify the class, propose a classification name, and follow the instructions to fill in the text box below.
Негізгі бет Ғылым және технология Efforts to Identify a Predicate - July 18 webinar
Пікірлер: 5