FDA has published the much-anticipated guidance for the de novo device application channel, and as promised has opened a new regulatory door that allows a device maker to avoid the need for obtaining a determination of not substantially equivalent (NSE) for moderate- and low-risk devices. The guidance calls for a sponsor to file a pre-de novo (PDS) submission as an alternative to wrangling with the 510(k) channel first, but a firm that obtains the agency's nod to go ahead with the de novo filing can file a parallel application for the device as a 510(k) and as a de novo. (Medical Device Daily) Read More
