The FDA just published "CDRH Event Problem Codes. This CDRH website (with enhanced device and patient problem codes) provides you a PREVIEW to the updates that will be going live July 1, 2009. The FDA provides this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes ‘go live’ and are accepted in MAUDE. It's important to note that on July 1, 2009 - CDRH will begin accepting the updated codes. DO NOT submit these updated codes prior to that time because they will be rejected. Until that time FDA says to continue to use the current Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes specified in this FDA update. The CDRH Event Problem Code initiative results in part, with updates to codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events.
Monday, April 6, 2009
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