MDSAP Audit Approach (MDSAP AU P0002) C4-T1-US: United States: maintain written MDR procedures and event files, report deaths, serious injuries and reportable malfunctions within 30 calendar days, 5-day reports where remedial action is needed, supplements within a month, with UDI and electronic submission

What does C4-T1-US require?

Manufacturers must report to the FDA deaths, serious injuries and reportable malfunctions linked to a device, wherever they happen, if that device or a similar one is sold in the US (21 CFR 803), with written procedures for timely identification, communication and evaluation of events, a standard reportability review, timely transmission of complete reports, and documentation and record keeping. Reports are due within 30 calendar days of becoming aware of information that reasonably suggests a marketed device may have caused, or contributed to, a death or serious injury, or of a malfunction that would be likely to do so on recurrence (quarterly summary reporting is allowed for most product codes); within 5 workdays where an event needs remedial action to prevent unreasonable risk of substantial harm or the FDA has asked in writing (with later similar events also reported); and supplemental reports within one month of new information. MDR event files must hold the deliberations and decisions on reportability, copies of submitted forms and explanations of any missing information, and be clearly identified where kept in complaint files; reports must match the complaint information, include the UDI and be filed electronically through the Electronic Submissions Gateway or the NextGen portal.