Unique Device Identifier Final Rule-FAQs-Part II
Did you know that September 24, 2014, is the first UDI DEADLINE for Class III devices, Stand-Alone Software, and devices licensed under the PHS Act?
Who is an Issuing Agency?
FDA has accredited three (3) agencies for the operation of a system to issue unique device identifiers. They are GS1 (www.gs1.org), Health Industry Business Communications Council (HIBCC) (www.hibcc.org), and International Council for Commonality in Blood Bank Automation (ICCBBA) (www.iccbba.org). GS1 and HIBCC are for medical devices, while ICCBBA is for medical products of human origin that are regulated as medical devices.
We sell single-use devices; do we need to label these products?
A UDI does not need to be placed on each single-use device (i.e., primary packaging). Instead, the UDI is to be placed on the secondary packaging (e.g., outer box). For example, exam gloves. The UDI label goes on the box, not each glove. This rule requires the package:
- Have a single version or model
- Be distributed together in a single device package
- Are intended to stored in that device packaging, and
- Are not intended for individual sale
Placement of the UDI on the secondary packaging for single-use devices does not apply to implanted devices. While implants are technically “single-use” devices, implants (defined as devices placed in the body for 30 days or longer) must have a UDI on the primary packaging. Federal Register – Single-use Devices
I understand there are implementation deadlines; what are they?
There are several deadlines related to this new regulation based on device Class. For example, Class III devices, Stand-Alone Software, and devices licensed under the PHS Act must be “compliant” and have a UDI on its package label, and information submitted to the Global UDI Database (GUDID) by September 24, 2014. There is an opportunity to file for a 1-year extension for these classes of devices under §801.55. The deadline for filing this extension is June 23, 2014.
Other implementation deadlines are (includes submitting data to GUDID):
September 24, 2015, Implantable, Life-Sustaining & Life Supporting Devices
September 24, 2016 Class II devices and Stand-Alone Software
Class III devices intended to be used more than once and reprocessed between uses must be directly marked with UDI
September 24, 2018 Class I devices and Stand-Alone Software
Devices not classified into Class I, II or III
Class II devices intended to be used more than once and reprocessed between uses must be directly marked with UDI
September 24, 2020 Class I devices, and devices that have not been classified as Class I, II or III, intended to be used more than once, and reprocessed between uses, must be directly marked with UDI
On-hand inventory labeled before the deadline does not need to be relabeled with a UDI for up to three (3) years past the deadline. FDA considers consignment inventory to fall under this rule. This requires that you track consignment inventory, as well as ensure the inventory is used before this three-year exception expiring. Federal Register – Implementation Dates
Our device is packaged one unit per package; do we need to label the device itself?
This is a “unit of use” issue. If you sell ten individually packaged devices ONLY in an outer pack, the individual devices do not require a UDI. Generally, labeling the outer pack with the UDI is sufficient. This assumes the device is stored and used that way.
I heard the information on our devices needs to be submitted to a “database.” Please explain?
UDI has been implemented to facilitate postmarket surveillance activities, including the identification of medical devices through its distribution and use. FDA believed a significant part of this was the ability for healthcare professionals and users to “search” a database to locate information about devices. This resulted in the creation of the Global Unique Device Identification Database (GUDID) system, which is a repository for 60-plus attributes for each Device Identifier and its corresponding Labeler information. Federal Register – GUDID Information
How do we submit data to the Global UDI Database?
There are two standard-based methods to submit date to the Global UDI Database (GUDID) – structured input via an FDA web interface, or using the Health Level 7 Structured Product Labeling (HL7 SPL) process. HL7 SPL is in XML format and uses the FDA electronic submission gateway as the pathway to input data into GUDID. To submit data to GUDID, you first need to request a GUDID user account from the FDA. Data is submitted one record at a time for both methods. There is no batch process. Federal Register – GUDID Submission
What additional information needs to be printed on a label under this new rule?
Medical devices must also follow labeling requirements detailed in Title 21, Subchapter H, §801, in addition to the new requirements per the UDI rule. Required information printed on the labels is also dictated by other regulatory agencies, such as the EU. Specifically, the UDI regulation requires a UDI be printed in easy-to-read plain text, and an Automatic Identification and Data Capture (AIDC) format and placed on the device label. The AIDC format is dictated by the format of the issuing agency you have chosen. The other label element FDA requires is the date format when a date is used on a label. The date format is YYYY-MM-DD, and a day must always be used. Federal Register – UDI Format
When do I need a new Device Identifier?
A new UDI is required when there is a change to a version or model. If you are calling the device a new version or model, and the users think the same, then it is a new device and requires a new Device Identifier (DI) and label changes. If the number of units in a device package changes – for instance, going from 5 to 10, then a new DI is required. This aspect often confuses people, as they think it has to do with changes in package artwork. Federal Register – New UDIs
Need More Information on how to design and implement a compliance plan for the Unique Device Identifier Rule?
FDA UDI Regulation on Medical Device Labelers is a complimentary webinar and PowerPoint training presented by subject matter expert, Jon Bretz. To access – CLICK HERE