By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn)
FDA Unique Device Identification (UDI) Final Rule and GUDID Guidance
FDA UDI Information
- UDI Rule and GUDID Guidance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidance
- Benefits of Unique Device Identification at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#benefits
- Compliance Dates for UDI Requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#compliancedates
- Accredited Issuing Agencies at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#agencies
On September 24, 2013, the Food and Drug Administration (FDA) has released a final rule (download it below) requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).
FDA UDI Application Examples
A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.
A UDI is a unique numeric or alphanumeric code that consists of two parts:
- a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
- a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- the lot or batch number within which a device was manufactured;
- the serial number of a specific device;
- the expiration date of a specific device;
- the date a specific device was manufactured;
- the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
Final UDI Rule Published in Federal Register, Dated 2013-09-24
As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.
The FDA has issued Global Unique Device Identification Database (GUDID) – Draft Guidance for Industry to give labelers an overview of the GUDID. This draft guidance is designed to help labelers prepare to submit information to the GUDID by describing key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions. The FDA encourages the submission of comments and suggestions regarding the draft GUDID guidance. Comments may be submitted according to the directions contained in the draft guidance. To ensure that the Agency considers a comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 25, 2013.
Download the UDI Final Rule 2013
- Read the Global Unique Device Identification Database (GUDID) Draft Guidance – September 24, 2013
Last Date Updated: December 20, 2014
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