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).
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),
Additional Information (AI) Requests are a part of FDA’s procedure to provide a medical device company with an opportunity to submit additional information missing from the initial submission. This information
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #3: Missing Software Bill of Materials (SBOM) Based on the information provided in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #4: Missing Software Version History You provided some software version history documentation in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #5: Missing Observed Results in Test Logs You provided software testing as part
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #6: Information on OTS used in the Device is Contradictory You provided documentation
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #7: Missing Software Unit Testing FDA is unable to locate the unit testing
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #8: Missing Version of a Test Referenced in a Report The XYZ Software
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #9: Missing Documentation on the Cybersecurity 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 #12: Missing Documentation on Differentiating Privileges Based on User Roles Required to Protect
