Unique Device Identifier (UDI) Final Rule

Unique Device Identifier Final Rule-FAQs-Part II

Screen Shot 2014 04 03 at 10.24.33 PM 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. To access – CLICK HERE

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Unique Device Identifier Final Rule-FAQs-Part I

Screen Shot 2014 04 03 at 10.23.51 PM Unique Device Identifier Final Rule FAQs Part IThis blog,Unique Device Identifier Final Rule-FAQs-Part 1,” answers questions, such as, what is a UDI? Who is responsible for applying the UDI label? Etc. 

What is a “UDI?”

The Unique Device Identifier (UDI) adequately identifies a device throughout the supply chain and while in use. It is constructed of two main sections – a device identifier and a production identifier. The device identifier is comprised of a permanently assigned product code (model or version) and a labeler identification code. The production identifier is a dynamic component and made up of a lot number, serial number, manufacturing date, expiration date, etc. The device identifier and production identifier together make up the UDI.  Federal Register – Unique Device Identifier definition

Who is responsible for applying the UDI label? 

FDA has defined the “Labeler” to be the entity responsible for applying the UDI label. This entity may or may not be the actual manufacturer. The Labeler is defined as the entity that causes a label to be secured to a device and who places the device into commercial distribution with the expectation the label will not be replaced or modified in any way. Additionally, should an entity replace or substantially modify the original label, and then place the device into commercial distribution with the expectation the label will not be replaced or modified in any way is also a Labeler. Distributors who simply add their name and address to the package are not defined as a Labeler under this definition. 

Private label devices present a situation where the actual manufacturer or brand name holder can be the Labeler. This would be a business decision between the manufacturer and the brand name holder. The Labeler may also be the specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.  Federal Register – Labeler definition

What does a “standardized” date format mean? 

FDA has decided for all human-readable dates (manufacturing date, expiration date, etc.) printed on labels must follow a YYYY-MM-DD format. The DAY is an absolute requirement. For example, March 31, 2014, must be presented as 2014-03-31. This requirement applies to ALL medical device classes that use a date on their label. Federal Register – Date format definition

I have kits that are comprised of several devices; how does this rule apply to me?

There are many types of kits. Kits can be made up of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to expedite a single surgical or medical procedure. §801.30(a)(11) states when a device is packaged within the “immediate container of a combination product or convenience kit, the label of the device will not be required to bear a UDI,” as long as the label on the kit has a UDI. Should your kit have a National Drug Code (NDC) number on its label, it does not also need to have a UDI.  §801.30(b)(3) clearly states devices that are included in a combination product with an NDC number on its label and does not have a UDI; the device components must bear a UDI on its label. Federal Register – Kits Exemption

What does reprocessing mean? 

FDA uses the term “reprocessing” in conjunction with a direct marking of a unique device identifier. Devices intended to be used more than once must have the UDI permanently marked directly on the device (with a few exceptions), and will be reprocessed between each use. However, the FDA has not yet defined what “reprocessing” means. I have asked FDA this question, with their response being they will “shortly” issue additional guidance on this matter. When they do, I will let you know via this blog. Until they do, use the following definition of “reprocessing” – clean, clean plus disinfected, or clean plus sterilized. Federal Register – Direct Marking and Device Reprocessing

We sell software that is considered a medical device; how do I label these devices?

Stand-Alone Software (SAS) regulated as a medical device must also have a UDI. SAS that is downloaded from the web and/or sold packaged must use the version number (as the lot number) in its production identifier. The full version of the UDI must be displayed in easy-to-read plain text, following the rules of the issuing agency you have selected, on the start-up screen and/or a menu command screen, such as the “About” screen. The UDI on the SAS packaged form may have the same device identifier. Federal Register – Stand-Alone Software

What is a device package? 

A device package is a package that contains a fixed number of a specific version or model of a device. The use of this term has often confused people who think it has something to do with the package design. Federal Register – Device Package definition

Do I need to label our shipping containers? 

A shipping container, for this regulation, is defined as a container used to ship or transport devices in which the items within may change from one shipment to another. The rule does not require a UDI label for any shipping container. Federal Register – Shipping Container

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