Brazil (RDC 665/2022 Art 121) and the United States (21 CFR 820.35(a)) require a formally designated unit to receive, document, evaluate and investigate complaints in a uniform and timely way, with oral complaints recorded on receipt. Each complaint must be reviewed to decide whether an investigation is needed; where none is done, the reason and the person who decided must be recorded. Complaints alleging that the device, labelling or packaging failed a specification must be investigated unless a similar investigation already covers them, claims of death, injury or public health threat must be reviewed immediately, and complaints that are reportable events must be promptly investigated by designated people and kept identifiable. Investigation records must include the device name, date received, unique device identifier or other identification and control numbers, complainant contact details, what the complaint alleges, in detail, investigation dates, results and data, corrective action taken, and for the FDA whether the device failed specifications, was in use for treatment or diagnosis, and its relationship to the event.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.