The US Food and Drug Administration (FDA) has recently made strides toward modernizing its 510(k) Program by issuing a draft guidance. The document, appropriately titled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification”, is one in a series of three documents released by the FDA for this purpose.
Predicate devices have a significant role to play in the 510(k) Program, serving as references for devices seeking market introduction. The draft guidance seeks to offer improved clarity on the choice of predicate devices, an aspect that is often pivotal in the approval process.
This move marks a significant step for the FDA in its pursuits to enhance efficiency and reliability in the medical devices market.
For more information, please refer to the original article written by ArentFox Schiff on JD Supra.