FDA Proposes New Medical Device ID System

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The Federal Drug Administration is proposing a new identification process for most medical devices distributed in the U.S., the agency announced Tuesday.

In 2007, Congress passed legislation directing the FDA to develop regulations for a unique device identifier.

The UDI would be a numeric or alphanumeric code and include a serial number, expiration date or lot or batch number.

Each identifier would also be specific to an individual product, the FDA said.

The agency said it is also developing a database to assist in identifying each UDI.

The FDA believes the UDI will help find problems with devices, track medical errors, provide a standardized global system and help manage product recalls.

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