ANSWERED ON THIS PAGE:
- How does the US FDA UDI system work?
- When must we comply with UDI system requirements?
- Which device classifications need to comply with UDI requirements?
Unique Device Identification (UDI) requirements for medical devices have been implemented by the US Food and Drug Administration (FDA). The FDA issued the final Unique Device Identifier (UDI) Rule and published it in the US Federal Register on 24 September 2013.
The UDI system final rule provides standard device identification and accompanying identifying information to support various public health initiatives, including support for the FDA’s post-market surveillance (PMS) activities. Manufacturers must meet UDI requirements as part of US market compliance.
UDI compliance requires a significant effort on the part of manufacturers. Emergo has carefully followed the development of UDI rules in both the US and international markets and has the expertise and resources to help you establish compliance processes to meet US FDA UDI requirements.
How the US FDA UDI system works
FDA UDI compliance involves more than etching a number onto your medical device or adding a barcode to your label. Several components are involved.
Each UDI must contain two numbers: a Device Identifier (DI) and a Production Identifier (PI). A Device Identifier must correspond to the specific model or version of a medical device and the company name. A Production Identifier must provide a medical device’s lot or batch information or serial number, expiration date, and related production data.
- Class I devices must be assigned device identifiers only. Class II and III devices must be assigned both device identifiers and product identifiers.
- Manufacturers must obtain UDI numbers only from FDA-accredited issuing agencies.
- All medical devices registered for sale in the US will have to include UDI information on their labeling and packaging.
- Devices intended for more than one use as well as devices requiring reprocessing before each use must also have UDI data marked directly on them.
- Manufacturers must provide UDI information in both plain-text (human readable) and AIDC (Automatic Identification and Capture) formats.
Manufacturers are required to submit UDI data into the FDA Global Unique Device Identification Database (GUDID) using proper formatting.
How Emergo can support your UDI compliance efforts
Emergo provides a comprehensive solution to support your UDI compliance efforts from beginning to end. Planning ahead allows you to identify internal resources, collect the appropriate data and make informed decisions to meet these requirements. Here’s how we can help:
- Identifying appropriate FDA-accredited UDI issuing agencies on your behalf.
- Product, labeling, and gap assessments for UDI compliance.
- UDI training and project management: we will work with your staff to execute a project schedule and minimize the impact to your resources.
- Assisting you to incorporate UDI processes into your quality management system and production operations.
- Ensuring proper UDI data formatting for submitting to GUDID.
- Guidance on supply chain management and validation to support UD implementation.
- And many other services.
Regardless of whether you are introducing a new medical device or looking for assistance in assuring compliance for existing devices in your product portfolio, our FDA consultants can assist with UDI compliance and training.
When must we comply with FDA UDI requirements?
The FDA’s UDI rules will not be fully implemented until 2020, but Class III and Class II (higher-risk devices) are required to comply. The FDA is extending the UDI requirement for Class I (non CGMP exempt) and Unclassified Devices. Emergo can help you assess when you must be in compliance based on your device classification.
What is included in Emergo’s UDI training?
You will learn:
- Overview of regulation requirements for UDI
- What products require UDI number and the timeline for implementation
- Review of the FDA Quality System Regulations (QSR), i.e. 21 CFR 801, 820, 830
- Guidance on choosing an Issuing Agency for a UDI number
- Information required for the UDI
- Product labeling and packaging requirements
- Maintenance and changes to packaging
How do we determine the GMDN code for our product?
The UDI system requires the manufacturer to input the Global Medical Device Nomenclature (GMDN) Code within the GUDID database. If you have not determined the GMDN Code for your product(s), Emergo can assist with this process.
We will research the potentially suitable code descriptions (the code number and code term are only available once requested from the GMDN Agency), provide the results, and request a code from the database.