Field safety corrective action

An FSCA can be a recall, a modification, a software update, extra checks or new advice to users. It is reported to the competent authorities and communicated to users through a field safety notice; the closest US concept is a correction or removal under 21 CFR 806.

‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

EU MDR, Article 2(68)

‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

IVDR, Article 2(71)