The UDI Toolkit provides companies responsible for class I devices, not familiar with the US UDI Final Rule and the FDA GUDID system, a definitive set of documents and templates to incorporate into its quality management system (QMS), processes and training to meet the FDA’s requirements by September 24, 2022.
The Toolkit provides documents to be used as a basis for understanding the regulatory requirements, assessing these requirements relative to your medical devices and regulated business process, and planning and implementing the processes and controls necessary for compliance. Final determination and implementation of these processes in a compliant manner remains the responsibility of the medical device company. Let’s get started.
Regulatory guidance, planning and execution services are available under separate agreements with USDM and are not provided as part of the Toolkit purchase.
How do I become UDI compliant?
There are five steps to becoming UDI compliant in the US:
- Assigning UDI to device labels and packages
- Printing UDI (AIDC and HRI) on labels and packages
- If applicable, providing a Direct Mark UDI on reusable devices.
- Collecting and submitting data to the Global UDI Database (GUDID)
- Incorporating UDI into your QMS
What does USDM’s US UDI CLASS I TOOLKIT provide to help achieve compliance?
To help achieve this compliance, the USDM CLASS I UDI TOOLKIT includes 7 definitive documents, priced at a flat fee of $5,000 USD:
1. UDI Training Presentation
This presentation provides an overview of US UDI requirements for class I devices.
2. Overarching UDI SOP, including QMS conforming amendments
This document stipulates the controls necessary for a device company to manage the FDA Unique Device Identification requirements established in 21 CFR Part §801 and §830, as well as the conforming amendments identified in the UDI Final Rule. This SOP applies to Class I devices. The document also defines the roles and responsibilities within the company related to UDI.
3. UDI Assignment Work Instruction, including requests for an Issuing Agency company prefix
The UDI DI Assignment Work Instruction defines the steps for assigning and managing the Device Identifiers (DI). The WI provides instructions on how to manually generate a DI (for device label and package. DI’s will need to be assigned to all existing and new devices. In addition, certain changes to specific device attributes will require either assigning a new Device Identifier, submitting data to GUDID, or both. The WI provides substantial definition and process details to determine which entities (devices, components, accessories, kits, repair parts, batteries) require DI’s and which do not. This is a comprehensive guide to determining and creating the DI for each product.
4. UDI Printing Work Instruction
The UDI Assignment Work Instruction defines the use and routine operation of the UDI Labeling and Verification equipment to generate and verify UDI labels for medical devices and device packages. The work instruction provides the framework to specify Responsibilities by Title, the relevant Definitions, and includes a framework to define the work processes including: Operation of the Workstation; Printing the UDI Label; Verifying the UDI Barcode on the Sample Label; Printing Labels Production Run; Barcode Verification Throughout the Production Run; any Special Processes for your operation.
5. GUDID Data Collection and Submission Work Instruction
This Work Instruction has been created to help collect the required meta-data to submit to FDA’s Global Unique Device Identification Database (GUDID). The Work Instruction provides the structure to define the responsibilities for data collection and approval. The document defines the data elements, provides the framework for the manufacturer to define where it will store the data as collected and GUDID data loading guidance including: GUDID Grace Period, Labeler DUNS Numbers, New DI Triggers, GUDID Data Element Change Rules, a Table of GUDID Data Attributes and relevant FDA Reference Document links.
6. GUDID Collection Template
The GUDID Collection Template describes each of 62 data elements with the following information for each when relevant.
7. FDA GUDID Account Creation Request
The FDA GUDID Account Creation Request includes the 3-page FDA Account Creation Form with an overview of the form and process to facilitate completion of the form and creation of the company’s account in the GUDID.
How will the US UDI CLASS I TOOLKIT help accelerate and guide my UDI compliance initiatives?
USDM has worked with hundreds of medical device companies to refine and perfect their UDI processes and procedures. Further, the US UDI CLASS I TOOLKIT was created by Jay Crowley, USDM’s Vice President of UDI Solutions. Jay is a recognized expert in UDI and held a variety of positions over his 26 years at the FDA, including developing the requirements for the FDA’s UDI system.
This unmatched expertise, built into the UDI Toolkit, will provide the following customer benefits:
- Provide a clear understanding of the steps necessary for UDI compliance
- Provide specific direction on the processes that must be followed for medical device companies
- Bring an understanding of the roles of QA, labeling, and supply chain
- Clarify the FDA processes and system access requirements
- Give labeling requirements to achieve compliance
- Spell out product data requirements and data submission processes
- Hand over SOPs and templates to incorporate into your QMS, to use for training and to facilitate your UDI processes to meet the FDA requirements by the September 24, 2022 deadline
The UDI Toolkit will fast-track your medical device compliance efforts by providing the necessary SOPs and templates to speed up your QMS processes and training. You, the medical device manufacturer, retain the responsibility to incorporate these SOPs and templates into a structured and compliant quality management system as required by the FDA. The UDI Toolkit is a substantial step to help you meet this meet this requirement and comes out-of-the-box ready for implementation.
What if I need further UDI support and assistance from Jay Crowley and the USDM UDI team?
To further assist Class I companies on their UDI initiatives, USDM also offers a set of prepackaged UDI regulatory consulting hours with Jay Crowley and the USDM UDI team. This prepackaged set of consulting and guidance hours can be added to the UDI Tool kit for an additional service fee of $6,000.
Learn more about USDM’s expert services for medical device companies.
With the USDM CLASS I UDI TOOLKIT, you and your leadership team will 1) understand the requirements, 2) have a structured set of SOPs and templates, 3) be prepared to plan activities, and 4) be ready to achieve UDI compliance by September 24, 2022.
Contact USDM today to speed up your UDI compliance!
Read on to learn more about USDM’s UDI capabilities and expertise.
Case Study: Improved UDI Data Integrity with Single-Source-of-Truth
Case Study: Quality System Upgrade to Meet EU MDR and EU IVDR
Webinar: Creating a Sustainable Global UDI Compliance Strategy
Webinar: EUDAMED and Labeling Requirements for EU MDR Compliance
Webinar: Are You Really UDI Compliant?
Blog: Most Misunderstood and Misapplied UDI Requirements