Maps to
21 CFR Part 803 (MDR): §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?
ISO 13485: §8.2.3 Reporting to regulatory authorities
Requirement text
When a manufacturer obtains information required under Part 803 that was not known or not available at the time of the initial MDR submission, the manufacturer must submit a supplemental or followup report to FDA within 30 calendar days of receiving that information. The manufacturer must submit the supplemental or followup report in accordance with the requirements of § 803.12(a), and on that report must indicate that the report being submitted is a supplemental or followup report; submit the appropriate identification numbers of the report that it is updating with the supplemental information, if applicable; and include only the new, changed, or corrected information.