FDA to expedite release of recall information

Douglas Stern, FDA’s Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs By: Douglas Stearn, J.D. When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak. Now, as part of a larger effort to increase transparency, empower consumers, and enhance public health, the FDA is working to alert the public sooner whenever a product has been recalled. The public’s primary source for recall information is FDA’s weekly, web-based Enforcement Report. Historically, only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report. Through classification, FDA indicates the relative degree of health hazard presented by the recalled product. This enables consumers to better understand the severity of the problem posed by a recalled product so they can take appropriate action. FDA also provides guidance to companies on their recall strategies, taking into account the seriousness of the hazard presented by the recalled product. However, recall classifications can sometimes take weeks – or even months when FDA needs to conduct a complex ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news