The FDA has two guidance documents explaining how to decide if a new 510(k) is required for device modifications: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-c... https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-s... This process for deciding when to submit a new 510(k) is also referred to as the "Letter to File" process. Companies ask our team for help with letters to file, but they seem to forget that they are required to have a procedure for design changes and they need to follow it. Therefore, this week's live-streaming video will walk you through the step-by-step changes for a typical "letter to file" device modification. If your company needs a procedure for design changes, training on design changes, or you want a copy of our letter to file form, please visit our website: https://medicaldeviceacademy.com/change-control-procedure/