We assist medical device manufacturers in navigating the FDA process to gain approval through De Novo classification for novel, low-to-moderate-risk devices without a predicate, ensuring compliance and a smoother path to market entry.
If you’re weighing De Novo versus 510(k) or PMA, start with two anchors: (1) Is there a legally marketed predicate with the same intended use and similar technology? (2) What is the risk profile, and can general and/or special controls assure safety and effectiveness? If a valid predicate exists, 510(k) is likely. If not, and risk is low-to-moderate with controls, De Novo may be the optimal route. If risk is high and cannot be mitigated with special controls, PMA is typically required.
De Novo is a classification – not just a one-off authorization. If granted, your device is classified as Class I or II, and may become a predicate for future 510(k)s, creating a competitive moat for early movers.
By regulation, De Novo is available for novel devices lacking a predicate where general controls alone or together with special controls provide reasonable assurance of safety and effectiveness. The core questions are: Can risks be enumerated? Are mitigations measurable and verifiable? Can special controls be defined to manage those risks?
When in doubt, a Q-Submission (Pre-Sub) is often the most time-saving first step to get FDA’s read on the appropriate pathway and data expectations before you commit to De Novo vs. 510(k)/PMA.
Timelines differ: MDUFA performance goals set target timelines for De Novo decisions, while 510(k) and PMA have their own metrics. Your plan should incorporate review clocks, interactive review, and potential Refuse to Accept (RTA) delays to keep the process on track.
