
Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).
Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually.
Continue Reading New Legislation Gives More Time for Medical Device Reporting