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)
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
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
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
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
