Discover the key differences between FDA’s 510(k) and De Novo pathways for medical device authorization. Learn when to choose each option, their requirements, timelines, and ideal use cases. From substantial equivalence in 510(k) to creating new classifications in De Novo, this guide provides essential insights for manufacturers. Ensure regulatory success with expert strategies and tailored support for your device’s U.S. market entry.

The FDA has introduced Elsa, a new AI tool designed to assist in medical device reviews, enhancing efficiency in 510(k), De Novo, and PMA pathways. Elsa operates securely without using confidential manufacturer data, aiming to speed up reviews and improve accuracy. While still early in development, it encourages manufacturers to prepare AI-ready submissions. This innovation marks a key step toward AI integration in regulatory processes, with ongoing human oversight and transp

The FDA Premarket Notification (510(k)) is essential for medical device manufacturers entering the U.S. market. It demonstrates that a new device is substantially equivalent to an existing, legally marketed device (predicate device) in terms of intended use and technical characteristics. Using the FDA's eSTAR template (mandatory as of October 1, 2023), the 510(k) process ensures device safety, effectiveness, and regulatory compliance. SANRUBIO, LLC offers expert guidance for

Transformation of the FDA's Medical Device Quality Management System Regulation – QMSR Regulation