What You Need to Know Now About Unique Device Identification

This blog was co-authored by Cathi Crist, partner, and Scott Gibbard, senior manager, Kalypso.

Part 1 of this series addressed the top six questions medical device manufacturers need to ask themselves to get ready for UDI. Medical device manufacturers were given one year to adapt policies, products, processes, and systems to meet the requirements of FDA 21 CFR Parts 16, 801, 803, et al. Unique Device Identification (UDI) System. Part 2 will cover what medical device manufacturers need to know about the FDA final rule system.

As the Sept. 24, 2014, Food and Drug Administration (FDA) Unique Device Identification (UDI) compliance deadline approaches for medical device manufacturers of class III devices, Kalypso experts provide analysis on the main changes made to the final rule and what they mean for the industry.  

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On Sept. 24, 2013, the FDA published its final rule for a system of UDI. Because the rule was a few years coming, industry insiders had time to get familiar with earlier drafts of the rule and let out a collective sigh of relief when they saw the final regulation--for the most part.

The core framework for the final UDI rule was mostly unchanged from the proposed rule published in early 2013:

Labels: As a general rule, all product labels for medical devices must bear a UDI—a combination of a device identifier (DI) and a production identifier (PI)—in both a human-readable form and a machine-readable form, using Automatic Identification and Data Capture (AIDC technology). All other cases where UDIs may not be required are considered exceptions to the general rule.

Database: Product data for all medical devices must be submitted and kept current in an FDA-managed Global Unique Device Identification Database (GUDID).

Direct Marking: Certain categories of devices must be have the DI directly marked on the device.

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 seven years.

Beyond this core framework, however, the FDA listened to feedback from the medical device industry and incorporated a number of meaningful changes to their original proposal. The final rule seems to strike a good balance of common sense and public safety, without overly burdening the industry.

Good for the Industry

Taken as a whole, the changes made to the final rule are mostly favorable to industry. In most cases the modifications were a result of legitimate industry concerns--e.g., a provision was too burdensome, inconsistent with other regulations, would not improve public safety, or some combination of all three.
 

Final Rule

Expert Analysis

All dates on labels intended to be read by users 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 (DM). Only devices intended to be reprocessed (disinfected or sterilized) prior to reuse will require a DM.

This eliminates concerns for potential added verification and validation activities for implantables. Direct marked DIs on devices implanted in human bodies had limited usefulness.

Stand-alone 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 stand-alone 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 must have UDIs--but not constituent parts. Combination products that already bear a national drug code (NDC) are exempt.

This relieves industry from the messiness of creating and managing new UDIs for constituent parts of kits or combination products.

Exceptions for DM need only be noted in the device Design History File (DHF). There is no need to apply for FDA exceptions.

 

This alleviates the considerable effort required to apply for and manage exemptions. Also, device DM may be done using both plain text and/or AIDC.

Single-use devices (SUDs) are exempt if they are distributed in a single device package and intended to be stored in that package until use, and are 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 exemption was extended to all classes of devices.

Minor additions/changes were made to the 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 by the final rule. Most changes should be easily accommodated by industry.

Some Aspects Are Tricky…But Still Beneficial

There are no significant modifications in the final rule that should catch the industry off guard. Some of the provisions, however, will be more difficult than others to implement.   
 

Final Rule

Expert Analysis

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 UDI, but it 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 Part 11.

If a manufacturer opts to use a third-party submission service, responsibility for Part 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 Part 830 of the federal registry. Eventually, the 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 regulations listed below. Manufacturers should keep UDI in mind as they make changes to these processes, procedures and systems:

Part 820 Quality System Regulation

Part 822 Post market Surveillance

Parts 803, 806, 810, 814 and 821

Not Much Time Left for Class III Companies

At the FDA UDI Conference in November 2013 it was announced that fewer than 100 GUDID accounts have been set up, despite industry estimates of there being over 700 companies with class III products. The FDA is providing feedback to companies that have submitted data and continues to refine its automated data validation checks, demonstrating continued commitment to cooperation with industry.  

Companies with class III products are aggressively assessing gaps in their own UDI programs and developing an implementation plan that will bring them to a state of UDI compliance. Other companies are not far behind.  The final UDI rule is good for the industry, and a positive example of how regulators and industry should work together to compromise on sensible laws that improve patient safety.

Part 3 of this series, "Jumpstart Your UDI Program," will be published in July and provide companies with the steps they need to develop their implementation plan. 

 

Cathi Crist, Partner at Kalypso, Cathi has over 20 years of engineering, product development, operations management and consulting experience across multiple industries with an emphasis in life sciences.

 

 

 

 

 

 

 

Scott Gibbard has over 20 years of engineering, product development and consulting experience across several technology and science-driven industries, with a particular focus in biopharmaceuticals.

Download this article in .PDF format
This file type includes high resolution graphics and schematics when applicable.

 

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