As required by 2012’s Food and Drug Administration Safety and Innovation Act, the FDA has submitted to Congress a report on premarket notification of changes to 510(k) devices. The agency will largely maintain the present guidance and policy framework and will publish a draft of its revisions for review. The agency will clarify terms in its regulations and provide guidance in determining in which cases to submit a 510(k) for changes to devices. It will add examples of modifications that do and do not need new submission, and information on documenting submission decisions. As appropriate, the FDA may provide guidelines for specific devices on what modifications might necessitate renewed 510(k) clearance. It will also create a separate guidance on 510(k) submission for changes to device software.

Source: FDA