The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]
As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, […]
Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For […]
A challenge in the fast-moving medical device industry is the maintenance of up-to-date information. The U.S. Food and Drug Administration (FDA) faces this challenge in keeping its various online resources current and consistent. While FDA […]
AAMIBlog 