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Requirement for U.S. FDA Unique Device Identification Next

Requirement for U.S. FDA Unique Device Identification

By Linda Chatwin

Time To Read 5 minutes

The Food and Drug Administration (FDA) released a final rule in September 2012, requiring most medical devices distributed in the United States to carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices.
See reference


Definition

A unique device identifier is a code placed on each applicable medical device and information entered into a global unique device identifier database (GUDID) which identifies specific device and production information about each device placed on the U.S. marketplace.

Scope and Requirements

Per FDA, device identification consists of the following, albeit Class 1 products do not require item 2, production identifier:

  1. Device identifier:
    • The proprietary/trade/brand name of the device
    • The version or model number of the device
    • The device labeler (the person who causes a label to be put on a device or the label modified and the device introduced into commerce)
  2. Production Identifier:
    • Variable information, such as the lot or batch, the serial number, expiration date, the date of manufacture, and, for human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated as devices, the distinct identification code required in 21 CFR 1271.290(c).
  3. Note that anytime a date is presented on a label, FDA requires a specific date format must be used: 4 digit year, followed by a 2 digit month, followed by a 2 digit date, and each element separated by hyphens: 2016-09-24.

In addition to specific device identification, information about the device is entered into the GUDID, which includes the device identifier, and each of the following items. Production identification found on device labels is flagged in the database, but is not required for each device manufactured:

    • If the device is direct marked, what the device identifier is, if it is different than the label of the device
    • Previous device identifier if the labeled device is a new version or model
    • The size of the device version or model
    • The type of production identifiers on the label
    • FDA premarket submission type, number and listing number(s)
    • The Global Medical Device Nomenclature (GMDN) term
      FDA product code (procode)
    • The number of individual devices in each package
    • Device characteristics, such as whether it is sterile, includes lot or serial number, whether expiration dates are used, and safety information related to latex and MRI exposure.
    • Other information is conditionally required, depending on device attributes, and some items are optional, such as the catalog number, device description (although highly encouraged), kit information, etc.

Why UDI is important

FDA has identified a number of important objectives with respect to the UDI schema. Medical providers will have access to information about devices available to them, and will be able to record specific information about devices that are used in medical treatments. The FDA objectives are stated as follows:

  1. Reduce medical errors
  2. Simplify the integration of device use information into data systems
  3. Provide for more rapid identification of Medical Devices with adverse events
  4. Provide for more rapid development of solutions to reported problems
  5. Provide for more rapid, more efficient resolution of device recalls
  6. Better focused and more effective FDA safety communication
  7. Provide an easily-accessible source of definitive device identification information

According to the notice of the final UDI rule UDI will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. Medical errors will be reduced since it will be possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use. This is because errors can result from misidentification of a device or confusion concerning its appropriate use.

In addition, the identification system established under the UDI rule is expected to lead to more accurate reporting of adverse events. Once UDI is implemented, the party who is reporting an adverse event will be able to identify the device that is the subject of the report.

Finally, FDA believes that UDI will allow FDA, health care providers, and industry to more gain insight into device issues by rapidly extracting information from the GUDID and adverse reports. This should help in understanding underlying device problems so they can be useful in corrective actions and in future device design.

Key dates in implementing the rule

The table below outlines key compliance dates for implementing elements required in the UDI final rule which can be found in Table 3 of the final rule. NOTE: There is 3-year exception for finished devices that are already labeled and in inventory at the compliance date. This means that finished and labeled devices do not have to be relabeled with the UDI on them during the 3 year period, but if they are still in inventory after this 3 year period, they must be re-labeled.

Regulatory Strategy

It is important for companies to develop a strategy early for compliance to the new UDI requirements. This is particularly important where a company has a number of individual models of devices that they sell on the U.S. market. FDA has cautioned companies to prepare early for GUDID submission, since there will be large volumes of information being published over the compliance date periods.

The strategy needs to include how to identify all product versions and models, what class they are in, what the current labeling scheme is, and perform a gap analysis on what needs to be in place for proper labeling in a timely manner under the rule. It is also necessary to determine the technology that the company will use for its barcoding, which FDA approved issuing agency it will employ, be prepared to set up the accounts that will be needed tor recording information in the GUDID, and how to get the proper resources for populating the GUDID.

Companies will need to know the options for entry into the GUDID, and realize that whether they choose the FDA web interface method, or the electronic HL7 SPL method, there is likely an equal amount of work to prepare, verify the data, and ensure that the entries meet FDA submission rules.

Companies will most likely need to identify a labeling software package that will meet the requirements of the rule for labeling, and know which resources they will need to design and implement new labels for products within the compliance date requirements.

Some nuances to the rule include:

  • Must employ human and machine readable identifiers
  • Production identifiers are not required on Class I products
  • GMP exempt Class I products are completely exempt from the UDI rule, however The day must always be included in the standardized date format. The month and year alone is not sufficient.
  • Single-use devices do not require the UDI on each individual device, but rather on the next higher level of packaging.
  • Stand-alone software must have the UDI in the software so it can be identified, since software is often virtual.
  • GUDID access for device entry is limited to those classes of devices within the compliance date range currently in effect. As that date passes, the GUDID access is available for the next compliance period.

Other Conforming Amendments

The UDI required a number of conforming amendments to other sections of the U.S. Medical Device Regulations. These sections are:

  • Part 803 – Medical Device Reporting
  • Part 806 – Reports of Corrections and Removals
  • Part 810 – Medical Device Recall Authority
  • Part 814 – Premarket Approvals
  • Part 820 – Quality System Regulation
  • Part 821 – Medical Device Tracking Requirements
  • Part 822 – Postmarket Surveillance

Companies should become familiar with the changes to these parts as they implement a UDI strategy.
Furthermore, as part of the UDI implementation, FDA will rescind NDC/NHRIC numbers no later than year 5 (September 2017). However, a manufacturer may continue to use an FDA issued NHRIC labeler code if the labeler submitted a request by September 24, 2014, to do so

How can UL help?

UL can assist companies to achieve compliance to the UDI rule by providing experienced resources to perform gap analyses, identify technology pathways, prepare project planning documents and assist in implementing the project plan. We can also assist in navigating the changes to the other sections of the Medical Device Regulations and ensure that companies are in compliance with these changes. Because the UDI rule is very complicated, often times companies do not have sufficient internal resources to continue with daily work, as well as take on the UDI compliance work, and UL can provide those needed resources.

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Author

Linda Chatwin, RAC is the North America Manager for UL’s Medical Regulatory Advisory Services team. Ms. Chatwin has worked in the medical industry for over 20 years and most recently served in global regulatory affairs for a multi-national medical device manufacturer. She has extensive experience in global medical device regulatory affairs, legal compliance and documentation and now supports manufacturers with advisory services to support global regulatory approvals and post-market quality system remediation.