Clinical Impact of Adverse Event Reporting

TABLE 2: Medical Device Reporting (MDR) Requirements⁽¹⁸⁾

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

1. event(s) necessitating "remedial action to prevent an unreasonable risk of substantial harm to the public health" or
2. 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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