FDA finalizes device identification rule

Thursday, September 26, 2013

WASHINGTON – The U.S. Food and Drug Administration (FDA) released a final rule Sept. 20 that requires manufacturers to mark most medical devices distributed in the country with a unique device identifier (UDI). The numeric and alphanumeric codes will identify the labeler and device model, and provide information about manufacture and expiration dates. The rule takes effect Dec. 23. Class III devices (high-risk) must carry the codes within a year; Class II devices (moderate-risk) within three years; and Class I devices not exempt from the rule within five years. In a bulletin to members, AAHomecare said the rule will benefit providers by providing better information in adverse-event reports. It will also help the FDA quickly identify product problems, specifically target devices for recall and improve patient safety.