StarFish July Medtech News + Insights is now online
July 9, 2019
StarFish July 2019 Medtech News + Insights is now online. In this issue: Patient monitoring devices and precision medicine Your summer plans Insights and observations...
November 26, 2013
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.