De Novo Policies Clarified In Final Guidance
A US FDA final guidance incorporates a 21st Century Cures Act provision that does away with a 30-day submission requirement for post-NSE de novo classification submissions and makes other clarifications.
You may also be interested in...
A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.
Following a user fee deal that will subject de novo applications to performance goals and user-fee payments, US FDA has proposed a guidance that attempts to explain its process for considering when to accept, and when not to accept, a de novo submission for review.
FDA granted more than double the number of de novo petitions in FY 2013 compared to past years, reflecting the availability of the direct de novo pathway recently established by Congress. De novo petitions allow a device that FDA deems to be low-to-moderate risk but without a clear predicate to enter the market without requiring a PMA.