FDA import alert: a potentially devastating enforcement tool.

The United States (US) operates strict measures to prevent foreign manufacturers from importing devices that it believes to be unsafe. The "Import Alert" issued by the Food and Drug Administration is a serious piece of legislation under which the device is detained and refused entry to the US until the manufacturer has taken corrective action. This article sets out situations in which an import alert would be issued, how manufacturers can avoid an import alert, and what to do if one is issued.