Weighing FDA pathways? If a valid predicate exists, 510(k) may fit. For novel, low-to-moderate risk devices, De Novo is optimal. High-risk devices typically require PMA. Use PreSub to confirm strategy, mitigate risks, and streamline approval.
If you’re weighing De Novo versus 510(k) or PMA, start with two anchors:
If a valid predicate exists, 510(k) is likely the appropriate pathway. If not, and the risk is low to moderate with controls, De Novo may be optimal. 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:
When in doubt, a Q-Submission (PreSub) is often the most time-saving first step to get FDA’s read on the appropriate pathway and data expectations before committing to De Novo, 510(k), or PMA.
Timelines differ among pathways. MDUFA goals set performance expectations for De Novo decisions, while 510(k) and PMA have their own review metrics. Your regulatory plan should incorporate review clocks, interactive review opportunities, and potential Refuse-to-Accept (RTA) delays.
