FDA Launches MedWatcher Application to Gather Data on Device-Related Problems

May 1, 2013 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has released a mobile application called MedWatcher, which allows individuals to submit voluntary reports of serious medical device problems to FDA using a smartphone or tablet, according to information posted on FDA’s website. Although use of the MedWatcher application will not fulfill mandatory reporting requirements for manufacturers and facilities, FDA relies on reports of serious problems with medical devices and other products as one important way to help identify and better understand the risks associated with these products. FDA believes that these reports, along with data from other sources, can provide additional critical information that can lead to improved patient safety and will help the agency identify and respond to safety signals and public health emergencies more efficiently and effectively.

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