Abstract
Field safety corrective actions (FSCA), communicated through field safety notices (FSN), are actions taken by manufacturers to reduce risk of death or serious deterioration in the state of health associated with use of medical devices (MD) that are already placed on the market. These may include return of the MD to manufacturer or its representative. As the European Medical Device Regulation has tightened up requirements to effectively guarantee safety after marketing, there is a need to identify a methodology to estimate administrative and clinical costs borne by healthcare providers and healthcare systems in case of MDs recalls.
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