The Unique Device Identification System for Class I and Unclassified Devices

The Unique Device Identification System for Class I and Unclassified Devices

In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have time to comply with the UDI system. This article reviews the purpose of the UDI system and requirements for Class I/unclassified devices.

Unlike pharmaceutical products, many medical devices did not have a unique identifier that clearly distinguished one product from another. The concept of a UDI system will provide many benefits to postmarket actions and surveillance, including:

  • more accurate reporting of adverse events by making it easier to identify the device
  • more rapid extraction of useful information from adverse event reports to enable more focused corrective action
  • reduce medical errors for misidentification or misuse
  • simplify the integration of device use information into data systems

While a consistent and standard way to identify medical devices through their distribution and use is desired, implementation can prove challenging. In order to address this, compliance with the UDI system was phased in over several years, starting with highest risk devices. For lower risk devices, FDA released a UDI Guidance for Class I and unclassified devices and certain devices requiring direct marking (issued on November 5, 2018). We break down the main ideas below.

So, what are the components of this UDI System?

  1. UDI

A device is required to be labeled with a UDI, either on the labeling/packaging or directly on the device (for reprocessed devices). Each UDI is issued by an FDA-accredited issuing agency and should be displayed in plain text and form that uses automatic identification and data capture (AIDC) technology (e.g., barcode).

Each UDI has 2 portions:

  • Device identifier – corresponds to the specific version or model of the device and the labeler of the device
  • Production identifier – more precisely identifies the specific device by providing variable information, such as the lot or batch, serial number, expiration date, and date of manufacture

 

  1. Submission of information to the Global UDI Database (GUDID)

Labelers must request a GUDID account.  Labelers then submit the device identifier and associated product information into the GUDID database.

I am manufacturing Class I/unclassified devices, what dates do I need to adhere to?

  • September 24, 2020 for enforcement of date formatting (year-month-day), labeling, and GUDID submission.
  • September 24, 2022 for enforcement of direct mark requirements, if appropriate.

I have finished Class I/unclassified devices that were made and labeled before September 24, 2018. What do I do with these devices?

Devices manufactured and labeled prior to September 24, 2018 are exempt from the requirement to have a UDI and GUDID data submission for a period of 3 years after the compliance date – that is, September 24, 2021.

I manufacture a single-use device. Does my device need a UDI?

Unless a single-use device is implantable, all individual single use devices do not need a UDI.

I manufacture a Class I device that by regulation is exempted from good manufacturing practice (GMP) requirements. Do I need to label my device with a UDI?

A Class I device exempt from the GMP regulation does not need to be labeled with a UDI, unless it has a specific recordkeeping requirement.

Manufacturers and labelers have a lot to consider in the implementation of UDIs. But with proper implementation, the UDI system can achieve its public health objectives.

Do you need assistance in preparing your medical device for marketing, or do you want to know more about the regulatory pathway for your medical device? Please contact us at (248) 987-4497 or info@emmainternational.com.

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