Making the Most of FDA's De Novo Classification Program
Fact Sheet
Sep 05, 2018
Medical devices and in vitro diagnostics

For companies looking to launch a novel, low-to-moderate risk medical device, the traditional pre-market notification 510(k) submission pathway may not be an option if no comparable (also known as ‘predicate’) device already exists in the market.

Legislation, passed and implemented in 1997, refined in 2012 and further clarified in the FDA’s 2017 guidance, now permits the FDA to streamline the classification process under the appropriate level of regulation based on the novel device’s risk profile.