The U.S. Food and Drug Administration (FDA) issues Additional Information (AI) Requests during the review of medical product submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), or medical device submissions. These requests are formal communications from the FDA to the sponsor or applicant, asking for clarification, more data, or supplementary documentation needed to complete the review process. AI Requests can address a wide range of issues, including clinical data, manufacturing processes, labeling, or statistical analysis. Their purpose is to ensure the FDA has all necessary information to make an informed regulatory decision while maintaining the safety, efficacy, and quality standards required by law.
AI Requests are typically issued when the FDA identifies gaps or uncertainties in the submitted information that cannot be resolved solely through internal review. Responding to an AI Request is a critical part of the regulatory process, and sponsors are expected to reply within a specified timeframe, often negotiated in advance or outlined in guidance documents. Delays or inadequate responses can prolong the review process or lead to non-approval. Timely and comprehensive answers to AI Requests help facilitate a smoother regulatory pathway and demonstrate the sponsor’s commitment to regulatory compliance and product quality.
The frequency of AI Requests for 510(k) premarket notification submissions is approximately 63% to 68% during the first review cycle. This marks a decrease from earlier years. For example, in 2010, about 79% of 510(k) submissions received AI Requests.
Over the next few months, I’ll be providing more examples of real-life FDA AI Requests. These are intended to provide insight into the FDA’s questioning and line of thinking. All examples are carefully redacted to remove any medical device company identifiable information.
I hope you find these examples to be both useful and informative in your development and submission efforts. I also hope these examples will allow you to avoid future AI Requests for upcoming submissions.
Please follow us to see more examples of AI Requests – a new one is released every week. Should you receive Additional Information Requests from the FDA, we’re here to help. Please give us a call to discuss and we’ll help you craft what you need to do going forward.
