The link provided is to the FDA Medical Device Reporting webpage. Although a number of the relevant regulation and some of the guidances are also posted separately, FDA has issued a number of amendments and continues to revise its interpretations of related compliance requirements; this FDA webpage is maintained and updatd directly by FDA. The MDR rule 21 CFR Part 803 defines what type of reports and time constraints apply for FDA reporting of significant field safety events or potential malfunctions that could lead to such events in the future.