T
tallu
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File
So, in the letter you only refer to "chapters of the book"?
So, in the letter you only refer to "chapters of the book"?
So, in the letter you only refer to "chapters of the book"?
I have used the letter to file method for small changes to make sure the regulatory files are complete. it is a defensible position when you don't want to file a completely new 510(k). there is a guidance document for this, which has been revised and superseded. try searching for "when to file a new 510(k)." The guidance document is titled "Deciding When to Submit a 510(k) for a Change to an Existing Device," it has a lot of information and good flow charts. "Letter to File" is listed as an option on pages 64 and 66 of this guidance document. url: Deciding When to Submit a 510(k) for a Change to an Existing DeviceHi,
I have come across the term "Letter to File" and "Add to File" on several occasion, when reading about "change of existing medical devices and 510(k)."
The FDA site gives no explanation of the term.
I suspect is it an unofficial term for a Special 510(k) though I´m not sure...
Does anyone use the term or know if it has an exact meaning?
regards t.