CFR

803.56—If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 1 month of the day that you receive this information. On a supplemental or followup report, you must:

(a) Indicate on the envelope and in the report that the report being submitted is a supplemental or followup report. If you are using FDA form 3500A, indicate this in Block Item H-2;

(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and

(c) Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports.

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