06 Jan Approach with Caution – The first Steps in UDI Implementation and Changes to the Code of Federal Regulations
In the second of a series of UDI Newsletters issued by Boston Biomedical Associates, the regulatory changes to the Code of Federal Regulations, how this will impact your business, and the first steps in the process for implementing a UDI system will be discussed. UDI implementation will present many challenges to medical device companies in coming years, and the best way to prepare is to be knowledgeable and organized.
Current State of Affairs
For those companies that have yet to implement the UDI system within their company, It is important to establish a Master Data file that contains the regulatory information on each product, as well as labeling information. This will create what the FDA refers to as a “Single Source of Truth” that will help companies avoid errors such as data duplication (1). Data quality will be of monumental importance in order to successfully implement a UDI system.
UDIs are Here to Help you!
Implementation of an efficient and effective UDI system is not as simple as obtaining a UDI for each device and putting it on the label. It is crucial to remember that the purpose of the UDI rule is to better enable device users and manufacturers to track and trace devices, resulting in improved supply chain security, and recall, AE, and post-market surveillance management (2). Consider the UDI rule as an opportunity to evaluate your company’s supply chain, and eliminate inefficiencies or noncompliances in your current business practices. It is also offers a chance to touch base with your stakeholders and get their opinion on the most effective use and placement of labels (3).
Taking the First Steps
Create a cross-functional team within the company to address the best approach to UDI Implementation. (4)
Class I and II manufacturers can learn from Class III Manufacturers that have already been through the process of implementing UDI. Companies attribute successful implementation on establishing cross functional teams early on in the process with the responsibility of developing the UDI implementation.
During this initial phase the team should consult clinicians, distributors, and other stakeholders about their use of the UDI, to validate assumptions on the use of product. This input can be added to a Market Specification document.
Another consideration is configurable products and kits. Determinations need to be made whether the package levels and/or combinations are practical and efficient, especially in terms of the new UDI regulations. The company should consider if it should continue with the same business practices or create a new sales specification for each device. (4)
Develop or Modify SOPs and Data dictionary
As with most changes to business practice, SOPs will need to be drafted or modified (if they already exist) to address UDI data management, labeling, verification of coding readability, and maintenance of a RA Database and Master database.
Determine your Company’s “Single Source of Truth”
This will require your company to determine what products are produced and how the products are labeled. This may seem like an easy task for small manufacturers, however larger manufacturers that have acquired other companies may need to complete an exhaustive review of all products they produce, including naming conventions.
To keep track of the manufactured products and associated regulatory information, it will be essential to create a list of all product codes and catalog numbers. Within this list, you should identify all codes for packages of multiple units and kit forms. Consider which ones are listed as Medical devices. Are they Spare Parts or Accessories and will they require individual UDIs? Data attributes for all identified products should be collected, verified, and entered into a controlled database. This database will allow your company to create a regulatory strategy for UDI Implementation. (4) (1)
Determine who the labeler of each device is
Again, this may seem obvious to some, however for many manufacturers there are multiple companies who handle the device before it is delivered to the user. As the manufacturer, you are responsible for identifying one party who will be responsible for the UDI and GUDID submissions. This will results in OEM/Distributor contracts being modified accordingly.
Changes and Additions to the Code of Federal Regulations (21 CFR)
The UDI rule effects requirements for device labels and packages, and also affects other parts of the Quality Regulation. The FDA made additions and changes to the Code of Federal Regulations, Title 21, Volume 8. These modifications went into effect in December 2013, however many of them do not become applicable until the specific UDI compliance dates become effective (see BBA’s November 2014 Newsletter). The modifications described below will have an impact on a company’s operating procedures.
The first modification is the most obvious. For each of the parts listed below, the requirement to use Unique Device Identifiers is being added to:
- 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
Other changes include:
- 801 Labeling Part A, section 801.3 was amended to add definitions for the Global Unique Device Identification Database and Unique Device Identifiers. (6)
- 830 UNIQUE DEVICE IDENTIFICATION Part B was added as a new section to discuss the regulatory requirements for UDIs. This chapter addresses exemptions, performance standards, records and reports for devices, and all other FDA UDI regulations (7)
Below is a detailed review of the changes made to the CFR parts listed above, and how they will potentially impact your company.
Table 1: Code of Federal Regulations, Title 21, Volume 8 Modifications and Potential Impacts (5)
What Does this Mean for You?
Unique Device Identifier Implementation is not something to jump into without forethought or preparation. It also offers a unique opportunity for companies to review their labeling protocols and supply chain and make improvements to help save money and improve work flow. Gathering a team within the company, seeking stakeholder input, creating a master database for product information and using these tools to put UDI measures in place will help avoid errors and data duplication. Boston Biomedical Associates can help you to modify SOPS, compile product data, and create a single source of truth. Although it is a challenge, in the end the UDI Rule established by the FDA will help the industry as a whole to gain better oversight over distribution and use of medical devices.
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- Expanding the Uses of UDI: Understanding the Critical Link between Clinical and Supply chain data. David Brooks, Corwin Lee, Doug Sabotin. Baltimore, MD : s.n., 2014.
- Unique Device Identifier – Purpose, Implementation and Challenges. Joanna Koh, Director, Operation & Policy, GDO. [ed.] Health Sciences Authority. 2012.
- UDI 2.0 What have we learned and where are we going? Jay Crowley, USDM Life Sciences. Baltimore, MD : s.n., 2014.
- UDI Journey – Our Past, Present, and Future. Jackie Rae Elkin, Medtronic, Inc. Baltimore, MD : s.n., 2014.
- Staff, Food and Drug Administration. Unique Device Identification System: Small Entity Compliance Guide. Guidance for Industry and Food and Drug Administration Staff. [Online] August 13, 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM409401.pdf
- Food and Drug Administration. TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION SUBCHAPTER H–MEDICAL DEVICES PART 801 LABELING Subpart A–General Labeling Provisions. [Online] September 01, 2014. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801&showFR=1
- Service, Department of Health and Human. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 [Docket No. FDA–2011–N–0090] Unique Device Identification System. Federal Register. [Online] September 24, 2013. http://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf