On Nov 21, 2013, the FDA published links to the De Novo Summaries. The significance of this is that these summaries may be used as a predicate for future 510(K) submissions.
The FDA published Guidance for De Novo Classification Process (Evaluation of Automatic Class III Designation) in 2011. The guidance is to facilitate a route to market for low or moderate risk devices that do not have a predicate and therefore have been classified as class III – device deemed to be not substantially equivalent (NSE) to legally marketed predicate devices.
Contact Vesna Janic, StarFish Medical Director of QA/RA, for information and advice on how this may impact your 501(k) submissions.