Clinical Impact of Adverse Event Reporting
TABLE 2:
Medical Device Reporting (MDR) Requirements(18)
NB: days refers to working days, unless otherwise specified
- User Facility:
-
- Deaths (to FDA and manufacturer within 10 days)
- Serious injuries/illnesses (to manufacturer within 10 days; to FDA if manufacturer unknown, also within 10 days)
- Semiannual Reports (to FDA) of all reports sent to FDA and/or manufacturer (due January 1 and July 1)
- Manufacturer:
-
- Deaths, serious injuries, malfunctions (to FDA within 30 calendar days of becoming aware of event)
- "5-day Report" [to FDA if become aware of
- event(s) necessitating "remedial action to prevent an unreasonable risk of substantial harm to the public health" or
- reportable event for which FDA has requested 5-day report]
- Annual Certification of number of reports
- Distributor:
-
- Deaths (to FDA and manufacturer within 10 days)
- Serious injuries/illnesses (to FDA and manufacturer within 10 days)
- Malfunctions (to FDA and manufacturer within 10 days)
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