510(k) vs. De Novo: Key Differences in FDA Approval Pathways for Medical Devices
Bringing a medical device to the U.S. market requires more than just innovation—it demands navigating the FDA’s regulatory framework. For devices that are not subject to the PMA (Premarket Approval) route, two primary approval pathways exist: the 510(k) clearance process and the De Novo classification request.
While both lead to market authorization, they differ in scope, eligibility, review timelines, and long-term regulatory impact. https://www.freyrsolutions.com..../blog/510k-vs-de-nov
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