In this series we provide 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’s identifiable information.
Our deep understanding of the medical device industry has resulted in FDA approval and European Union CE Mark for hundreds of devices from all FDA classes (I, II, and III) and IEC 62304 software safety classifications (A, B, C).
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #13: Incomplete Software Requirements Documentation You provided Software
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #14: Inadequate Risk Management Information You provided Risk
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #15: Inadequate Information on the Confidentiality Controls used
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #16: Missing Cybersecurity Risk Assessment Documentation Based on
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #17: Lack of Documenting the Final Version Number
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #18: Off-The-Shelf Software In your software description, you
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #19: Missing Adequate Information on the Availability Controls
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided in your submission, your device meets the definition of
Here’s this week’s example of an Additional Information Request (AI Request): Your submission documentation indicates that you are using YYY as the operating system (OS)
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided, it is not clear how the device detects, monitors,
