A 510(k) submission to the U.S. Food and Drug Administration (FDA) is a premarket notification required for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. The submission must be well-organized and comprehensive. Below is a typical Table of Contents (ToC) structure for a 510(k) application, including sections and subsections: 1. Cover Letter Applicant […]
Archive for March 3rd, 2025
510K Template / Table of Contents for Medical Device
Posted by Michael A. S. Guth on March 3rd, 2025