What happens after the Substantive Review and AI response in the traditional 510(k) process?

Question

After the Substantive Review in the traditional 510(k) process, and after receiving and responding to the Additional Information (AI) request within the 180-day deadline, is the final 510(k) decision letter issued at this point? Or, if the FDA still has additional concerns, does another review round start with more time to respond, or is this already the final step?

Dr. Oliver Eidel · Accepted Answer

After you submit your response to the AI request, the FDA generally has 30 days to review it and make a decision. If they have additional questions, they'll reach out during this period, and each new question will pause the review clock. If there are no more questions, you should get the final decision letter in about 30 days after your response.

Answer

In our experience, after submitting the AI response, we had some additional questions from FDA in an interactive review phase. These were handled via email and required quick responses and sometimes minor changes, such as to labeling. So, there can be some continued communication before the final decision is issued.

What happens after the Substantive Review and AI response in the traditional 510(k) process?

2 Answers

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