De Novo Submissions– Bethany Hills, Chair, FDA Practice

a de novo submission is a specific type of a submission for class to designation of products that don't have a predicate so the way it works is the FDA has a structure in place where all of our devices are classified by risk class one two and three and a class two device often is going to require what we know of as a 510 K submission a de novo submission is a submission that you request a designation of class 2 from the FDA when there's not a predicate device the 510 K submissions actually use a predicate device to establish substantial equivalence so there's a significant difference there are three things that are really different about a de novo submission compared to a 510 K submission the first one is the inclusion of a risk benefit analysis that is important it's necessary to make the argument to the FDA that your product is a class 2 risk level and not a class 3 the other thing that is missing from a de novo submission is the substantial equivalence discussion because there is no predicate that you're claiming substantial equivalence to you don't include that aspect in the submission and the third piece is clinical data often there is going to be a requirement to show the FDA that you are a class 2 risk that you're not a class 3 risk and that is usually a very critical component so in order to convince FDA that you are not a risky class 3 product that you really are a class 2 product one of the things you can include is special controls and the special controls can be anything from labeling to specific types of product performance or even patient education or provider education on the product those special controls can help you with your designation as a class 2 but they also can be a competitive advantage which would make it difficult for follow-on products to copy your product because they will have to comply with all those special controls also

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