Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, only few IVD as specified in Annex II ...
recall (redirected fromField Safety Corrective Action) Thesaurus Medical Legal Acronyms Encyclopedia re·call (rĭ-kôl′) tr.v.re·called,re·call·ing,re·calls 1.To ask or order to return:recalled all workers who had been laid off. ...
Background information and reason for the FSCA: Description and justification of the action (corrective/preventive) Advice on actions to be taken by the distributor and the user.Attached please find □Field Safety Notice (FSN) in English □FSN in national language □Others (please specify...
In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed...