Regulatory Pathway
Also known as: Regulatory Strategy, Route to Market Authorization
The route a product must follow to gain authorization for sale in a given market, set by the product's classification and the jurisdiction.
Full Definition
For medical devices in the United States, the main pathways are 510(k) clearance, De Novo classification, and Premarket Approval (PMA). In the European Union, medical devices and in vitro diagnostics follow conformity assessment under the MDR or the IVDR, usually with a notified body, leading to a CE mark. Drugs and biologics follow separate routes, such as an IND followed by an NDA or a BLA in the United States.
The pathway determines the evidence required, the time to market, and the cost. Investors expect it to be identified early. In the Funding Readiness Rubric, a defined regulatory pathway with an estimated timeline is a Must Have criterion at the Seed level wherever authorization is required.
A team developing software that flags sepsis risk confirms that its product is classified as software as a medical device. It identifies a predicate device, selects the 510(k) pathway, and builds its development plan around the evidence a 510(k) requires.