23 Sep What the FDA 510(k) vs De Novo Decision Means for a Device Startup Timeline
For a medical device startup, the choice between a 510(k) clearance and a De Novo authorization is one of the most consequential regulatory decisions the company will make. It affects how long the regulatory process takes, what evidence must be generated before that process begins, how much it costs, and what market position the company occupies once authorization is achieved. Getting this decision right early — ideally before significant development spending has occurred — is among the highest-return investments available in the regulatory strategy phase. According to the FDA (U.S. Food and Drug Administration), the 510(k) and De Novo pathways serve fundamentally different regulatory purposes, and selecting the wrong one early can add significant time and cost to the path to market authorization.
[caption id="attachment_76192" align="aligncenter" width="500"] Image by uh44464 on Magnific[/caption]