July 2012 Posts

FDA Wants Unique Device Identification System for Medical Devices

FDA Wants Unique Device Identification System for Medical Devices

Mark Crawford

On July 3 the U.S. Food and Drug Administration proposed that most medical devices distributed in the U.S. must carry a unique device identifier (UDI). The hope is that this system will improve speed of response to adverse events reports, identify and issue target recalls more efficiently, and improve patient safety. (more…)

Key Reminders for Managing Suppliers

Key Reminders for Managing Suppliers

Mark Crawford

Supply chain management is harder than it used to be. Many OEMs are outsourcing more functions instead of keeping them in-house, adding geographical distance and cultural diversity to the supply chain. This, of course, adds complexity as well, which increases the chances of something going wrong and compromising quality. (more…)

PMA Submission Helps Medtronic Win Lawsuit

PMA Submission Helps Medtronic Win Lawsuit

Mark Crawford

After a five-day bench trial in February, Judge Mark Davis, U.S. District Court-Eastern Virginia, rejected a lawsuit brought by W.L. Gore & Associates against Medtronic. Gore claimed that Medtronic violated a patent it holds on the manufacturing process for making intraluminal stent grafts used for treating aneurysms. (more…)

Managing CAPA Requires a Strong SOP

Managing CAPA Requires a Strong SOP

Mark Crawford

According to Nancy Singer and Mark Lagunowich in their informative MD+DI article entitled “Getting Your CAPA House in Order,” CAPA (Corrective and Preventative Action) remains one of the top FDA 483 citations year after year, due typically to “either inadequate processes or inconsistent adherence to processes,” they write. “This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.” (more…)