If FDA requests additional information for an MDR under 21 CFR 803.15, you are encouraged to submit the response electronically.
A manufacturer responding to an FDA request for additional information, using the 3500A format, should enter the initial report number, indicate in Block H2 that the type of follow-up is a “Response to FDA Request,” and provide the requested information in Block H10/11, Additional Manufacturer Narrative. Any discrete data elements should also be reported in Block H10/11. You may submit the letter you received as an attachment to the submission.
The FDA request for AI may give the manufacturer the option to respond using email to the FDA sender. The manufacturer’s email response should include the identifying information specified in the AI request.
A communication from FDA to a user facility or importer that requests additional information will provide instructions for responding to the sender. That response should include the identifying information specified in the AI request.
