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FDA finalizes device identification rule

September 26, 2013HME News Staff

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...

AAHomecare, Food & Drug Administration (FDA), unique device identifier

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