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 supplemental report must be submitted per the requirements of §803.12(a), must clearly indicate that it is a supplemental or followup report, must reference the identification numbers of the original report, and must include only the new, changed, or corrected information.