Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k)

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of...