Medical device labeling and advertising: an overview.

The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims.

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.