Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File
The references of "letter to file" or "add to file" pertain strictly to internal documentation. There is no regulatory requirement to provide this type of documentation directly to FDA. When it comes to changes to a medical device, here are the regulatory options:
1. Documented per QSR design & change control requirements (no "letter to file")
2-Same as #1, but including additional documentation, e.g. the "letter to file" that, in essence, explains why no 510(k) is required.
3-Same as #1 + Special 510(k)
4-Same as #1 + Abbreviated 510(k)
5-Same as #1 + Traditional 510(k)