Article on 510(k) Analysis Added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, has an article, Documenting Changes Using the 510(k) Guidance, that explains the changes in a medical device and when they trigger the threshold for a new 510(k).

A manufacturer can change a device using either a design change or a production/process change. Evaluate each change to determine if it triggers a new 510(k). If it does not, review all changes since the most recently cleared 510(k) to determine if the cumulative changes trigger a new 510(k).