After submitting a 510(k), active communication and timely responses to FDA questions—especially Additional Information requests—are key to keeping the review on track. Clear, complete, and well-coordinated replies improve your chances of swift clearance.
Submitting your 510(k) is the culmination of months of work, but the review process continues until the FDA issues a decision. Understanding how to manage post‑submission communication and respond to Requests for Additional Information (RAIs) is critical to obtaining clearance.
During the substantive review, FDA reviewers may contact you informally to clarify minor questions or request small changes. Respond promptly and provide clear explanations or revised documents. These interactions help maintain momentum and may prevent formal RAIs.
If reviewers identify deficiencies, they issue an AI request. Your submission is placed on hold and the “FDA days” clock stops. Sponsors have 180 calendar days to respond; failure to respond results in withdrawal of the submission. The AI request will list specific questions or data gaps. To address it:
Maintain open dialogue with your lead reviewer. If questions in the AI request are unclear, ask for clarification. If new data will not be available within 180 days, contact the reviewer to discuss alternative solutions. Keep a record of all communications and decisions.
After you submit your AI response, the FDA resumes the review. The reviewer may accept your answers, request further clarification or, in rare cases, issue a second AI request. Monitor the review status and address any follow‑up questions quickly. Once all deficiencies are resolved, the FDA issues a Substantially Equivalent decision, allowing your device to enter the U.S. market.
Properly managing post‑submission support and AI responses shows the FDA that you are responsive and thorough, reducing the risk of a Not Substantially Equivalent outcome. Prepare for potential questions during product development and allocate resources to respond promptly.
