The final version of the guidance gives the manufactures an update of reliable decision criteria for information towards the FDA for changes concerning the product.
The 2017 guidance supersedes the 1997 version.
The current guidance preserves the basic format and content of the original, with updates to add clarity.
If a manufacturer determines -based on the updated guidance - that the device change(s) does not require submission of a new 510(k), it should document the decision-making process and the basis for that conclusion.
The documentation should be prepared in a way that an FDA investigator or other third party can understand what the change is and the rationale underlying the manufacturer’s conclusion that submission of a new 510(k) is not required.
The final guidance "When to submit a new 510(k)" is available on the FDA Website.
It is important to notice that this guidance does not address software changes or modifications. Please
Device for recommendations regarding software changes.