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U.S. Department of Health and Human Services

Medical Devices

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Unique Device Identification (UDI) Proposed Rule

 

July 3, 2012

 

 

 

The FDA is pleased to announce that we have issued a proposed rule on the establishment of a unique device identification system.

 

This very important proposal is a first step towards a standardized way to identify devices across all information sources and systems. As you will read, we are proposing a phased-in, risk-based approach to its implementation, focusing on the highest-risk medical devices and exempting low-risk devices from some or all of the requirements.

 

The proposal builds on standards and systems currently used by the device industry, reflecting the substantial input we received from the clinical community, other regulators and industry experts.

 

We will collect comments on the proposed rule for 120 days—you may submit comments by following directions in the proposed rule.

What is a UDI?
  • A UDI is a code that will contain two types of information: a unique numeric or alphanumeric code, called a Device Identifier, which is specific to a device model, and a Production Identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. While the UDI will appear on the label and packaging of devices, in some cases the UDI would be marked on the device itself (for example, implantable devices and devices that are intended to be used multiple times and sterilized after each single use). Low-risk devices that are not completely exempted from the rule will only be required to have a device identifier on their labels.
What is the unique device identification system designed to accomplish?
  •  The UDI rule was developed in response to a number of needs, including:
  • Requests from industry to have more a harmonized approach to standardized device identifiers.
  • The need of the clinical community to be able to better identify medical devices.
  • The need to document device use in electronic health records.
  • A need to more accurately identify devices in adverse event reports.
  • A need to more quickly and efficiently identify recalled devices.

A desire to improve visibility as devices move through the supply chain up to the point of patient use.

What will the UDI be connected to?

The proposed rule would establish a system of unique device identification that includes (1) a UDI represented both in plain text and through automatic identification and machine-readable (AIDC) format, such as a bar code, and (2) a publicly available database, the Global Unique Device Identification Database (GUDID), containing a defined set of information for each device.

What devices will be required to have a UDI and when?

The FDA is proposing a phased-in, risk-based approach to UDI implementation, focusing on the highest-risk medical devices and exempting low-risk devices from some or all of the requirements. The proposed system also builds on standards and systems currently used by the device industry, reflecting substantial input received from the clinical community, other regulators and industry experts.

 

The proposed rule contains a set of draft requirements and effective dates for implementation.

 

Additional information:

UDI Web Site

FDA Press Release

 

Thank you for your support of FDA and its mission.

 

 

Sincerely,

 

Center for Devices and Radiological Health

Food and Drug Administration