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FDA's Final UDI Rule: A Few Tricks But Mostly Treats

Article-FDA's Final UDI Rule: A Few Tricks But Mostly Treats

FDA's Final UDI Rule: A Few Tricks But Mostly Treats
The final rule for unique device identification is mostly favorable to industry, but some provisions of the rule could be challenging to implement.

On September 24, 2013, FDA published its final rule for a system of Unique Device Identification (UDI). The rule has been a few years coming, so industry insiders that had time to get intimate with earlier drafts of the rule likely let out a sigh of relief when they saw the final version.

Don't miss the conference session on "The Next Steps in UDI Implementation," presented by GS1's M.J. Wylie, at MD&M Minneapolis on October 28, 2013.

The core framework for the final UDI rule is mostly unchanged from the proposed rule published earlier this year:

  • Labels. As a general rule, all product labels for medical devices must bear a UDI—a combination of a device identifier and a production identifier—in both a human-readable form and a machine-readable form, using Automatic Identification and Data Capture (AIDC technology). All other special exceptions and exemptions, where UDIs may not be required, are exceptions to the general rule.
  • Database. Product data for all medical devices must be submitted and kept up to date in an FDA-managed Global Unique Device Identification Database (GUDID).
  • Direct Marking. The device identifier must be directly marked on certain categories of devices.
  • Timeline. Compliance dates take effect over time using a risk-based approach. For example, labeling and GUDID submission requirements are phased in by device class over a five-year period, while direct marking compliance requirements are phased in over a seven-year period.

Beyond the core rule, however, FDA listened to feedback from industry and incorporated a number of meaningful changes to its original proposal. The final rule strikes a good balance of common sense and public safety without overly burdening the industry.

The Treats

Taken as a whole, the changes made to the final UDI rule were mostly favorable to industry. But that’s not to say they were giveaways. In most cases, the modifications were a result of legitimate industry concerns—a provision was too burdensome, was inconsistent with other regulations, would not improve public safety, or some combination of the above.

Here’s a look at some of the changes and how they benefit industry:

  • Labels will require international date format of YYYY-MM-DD and all devices will adopt the Global Medical Device Nomenclature (GMDN) coding system.
  • Although this adds effort in the short term, standardization on international date format and the GMDN coding scheme is a great step toward harmonization of standards for medical device global commerce.
  • Implantable devices will not be required to bear direct marking. Only devices intended to be reprocessed prior to reuse will require a direct marking.
  • This eliminates concerns for potential added verification and validation activities for implantables.

  • Standalone software is no longer listed under “direct part marking” and will only require a means of displaying the UDI in a human-readable format.
  • It never made sense to include standalone software under direct part marking language (how exactly do you etch an identifier onto software?). The final rule is sensible.
  • Existing inventory will have a three-year grace period to distribute manufactured and labeled products prior to compliance date.
  • This provides a cushion for industry, which will not face decisions of how to redirect finished goods inventory that is not in compliance.
  • Convenience kits or combination products–but not constituent parts—must have UDIs. Combination products that already bear a national drug code are exempt.
  • This relieves industry from the messiness of creating and managing new UDIs for constituent parts of kits or combination products.
  • Exceptions for direct marking need only be noted in the device design history file; no need to apply to FDA exceptions.
  • This alleviates industry from considerable effort to apply for and manage exemptions. Also, direct marking of devices may be done using both plain text and/or AIDC.
  • Single-use devices are exempt if they are distributed in a single device package and intended to be stored in that package until use, and not intended for individual commercial distribution.
  • This mitigates concerns that items individually packaged within larger boxes (e.g., bandages) would require UDIs on the individual package. This requirement was extended to all classes of devices.
  • Minor additions/changes were made to list of product attributes required to be submitted to the GUDID (e.g., MRI compatibility– safe, unsafe, conditional).
  • There were no wholesale changes to the product attributes required for the GUDID. Most changes should be easily accommodated by industry.

The Tricks

There really were not any crazy new tricks added to the final rule that would have caught the industry off guard. The following provisions, however, will be trickier than others to implement:

  • No broad exceptions were granted for over-the-counter (OTC) devices. Class I devices labeled with a UPC code can use that code as the UDI but must meet all other UDI requirements, including database submission.
  • FDA was clear that it was never its intention to exempt OTC devices from the system for unique device identification. But the agency also did not wish to create redundancy with UPC codes that accompany all devices sold at retail. The final rule is a sensible compromise.
  • HL7 Structured Product Label (SPL) format was retained as the required format for bulk uploads to the GUDID.

  • While the use of SPL for FDA submissions will support transmission of many records simultaneously, it will undoubtedly cause the occasional headache with transmission rejections and evolving SPL standards. Manufacturers will need to maintain traceability on these records to assure that all acknowledgements are received and ultimately accepted.
  • Systems and solutions developed and implemented to manage GUDID data and submissions will be subject to 21 CFR 11.
  • Should a manufacturer opt to use a third-party submission service, responsibility for 21 CFR 11 compliance and data validation will remain with the manufacturer.
  • Implementation of a compliant UDI program will not end with the adoption of all the provisions in the final UDI rule contained in 21 CFR 830. Eventually, FDA will publish amendments to many of the other regulations that govern the medical device industry, and industry will need to ensure compliance with these amendments.
  • Conforming amendments are expected in the following regulations. Manufacturers should keep UDI in mind as they make changes to these processes, procedures, and systems:
  1. 21 CFR 820 Quality System Regulation
  2. 21 CFR 822 Postmarket Surveillance
  3. 21 CFR 803, 806, 810, 814, and 821

The Final UDI Rule is Good for the Industry

FDA senior advisor for patient safety Jay Crowley and his team raised a glass of sparkling cider to industry attendees at the FDA UDI Conference in Baltimore on the morning of September 24, 2013, when they announced that the final rule had been accepted. We believe the industry is right to raise a glass to toast the arrival of the final rule. Now that we all know what that target is we are working toward—and that target looks pretty reasonable—companies can get on with the business of assessing gaps in their own UDI program and developing an implementation plan that will bring them to a state of UDI compliance. After that, the future holds many opportunities for additional longer-term benefits from UDI.

Learn more about how to implement UDI at the MD&M Minneapolis conference.

Cathi Crist is a partner with Kalypso. Scott Gibbard is a senior manager.

[image courtesy of FDA]

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