Keyword Analysis & Research: 510k add to file

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Frequently Asked Questions

What is the difference between add-to-file and special 510k?

From my experience, "Add-To-File" was a previous version of "Special 510k". Before when you had a major change to a current product 510k, you would submit the changes to the FDA under "Add-To-File" which meant "Add To the current 510k File". Now you submit the changes under "Special 510k".

What is a 510 (k) letter to file?

files (often known in the medical device industry as a “letter to file” or “memo to file”) which may be reviewed during FDA inspections. Many types of changes may be implemented over the product lifecycle by 510(k)

Can a new 510K be submitted for an existing device?

Submission of a New 510 (k) for a Change to an Existing Device There are no provisions for a 510 (k) amendment or supplement to the existing 510 (k).If it is determined the modification is not covered by the current 510 (k) a new 510 (k) must be submitted.

What is a “catch-up” 510 (k) and should I submit one?

In such circumstances, a 510(k) holder may choose to submit a “catch-up” 510(k) in an effort to mitigate the risk of a Form 483 or “Warning Letter” resulting from an FDA inspection. A 510(k) holder also may wish to consider submitting a “catch-up” 510(k) to facilitate international product registrations.

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