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 Requirements Specification (SRS) documentation in
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 Management File documentation in your
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 to Protect the Device You
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 the information provided in your
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 of the Software and Firmware
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 provided information about the OTS
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 used to Protect the Device
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 a cyber device under Section
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) for the device. This 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, logs, and/or alerts users of
