The FDA's New UDI Labeling Format

We can supply Tyvek packaging printed or unprinted with or without barcodes for your device packaging. These would be in a batch format without serialization. We can also supply Unprinted or Preprinted adhesive label. Please see below for an overview of the FDA GUDI initiative 

 

UDI Label

What is included in the UDI Information and Structure

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with an identifier.

There are two elements that make up the UDI, the DI and the PI. A DI is a Device Identifier which is a fixed numeric or alphanumeric string that uniquely identifies the labeler and the specific version or model of a device. The PI or Production Identifier is a variable production control including the lot number, serial number, manufacturing date and/or expiration date.

A UDI includes two segments: a device identifier (DI) and a production identifier (PI). The GTIN (“UPN”) can serve as the DI. The other UDI segment, “PI”, is required if PIs appear anywhere on the device label or package.

The U.S. FDA UDI Rule does not require any specific PIs. It simply requires that whatever PI(s) appear on the device label or package (for whatever reason) must also be included in the UDI.

Under the UDI final rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.

According to the UDI final rule, “The labeler is the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.”

If all the information required by the UDI is able to fit on your existing label, there is no need to update, but if the print is too small or there is information missing, a printer capable of printing on larger labels, may be necessary.

While many products are already barcoded, many of them may not be compliant with the new UDI regulation. A UDI is not a randomly self-generated code, or created by your company. It must be approved by the FDA and issued by one of the three companies that have received special FDA accreditation. The Device ID must also be registered in the FDA's Global Unique Device Identifier Database before it may be used on a UDI label.

The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but the GUDID will contain production identifier flags to indicate which PI attribute(s) are on the device label.

Single Use Devices (SUDs)

Packages containing the individual SUDs must be labeled with a UDI, but individual items in that package do not (assuming they're of a single version/model and not intended
for individual sale). For example, a box of bandages must have a UDI, but the individual bandages contained in the box do not. (NOTE: any implantable devices are not included in the above exception)

UDI Requirements

The FDA GUDID database requires approximately 60 fields of data to be provided for every Device Identifier, including device description, company information, packaging information, storage and handling conditions, sterilization information, ect.

This new UDI ruling requires all labeling to be readable by both humans as well as machines (usually in the form of a barcode). Due to the amount of information required by the FDA, new labels may need to be bigger than the existing ones, as using smaller fonts may not be readable by humans.

If the product intended for use may be separated from it's packaging or pouch, it is required that both parts have a DUI label. For instance, if a product is shipped in a cardboard box with several individual pouches inside, the box must me properly labeled, as well as each pouch within the box.

For FDA Guidelines and Submission, Please visit the following sites

The GUDID provides two options for submission of device identification information:

  1. GUDID Web Interface – enables structured input of device information as one DI record at a time.
  2. HL7 SPL submission – enables submission of device information as xml files
  3. The public can access information contained in the GUDID through AccessGUDID.

Both submission options require a GUDID account. GUDID device information submission is currently open only to labelers of currently marketed class III medical devices, devices licensed under the Public Health Service Act (PHS Act), and implantable, life-supporting, or life-sustaining devices.

The GUDID is being populated with data about devices according to the compliance timeline in the final rule. GUDID accounts are NOT required for search and retrieval of published information in AccessGUDID, the public portal for GUDID data.

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  • Unprinted Tyvek packaging or labeling

FDA Final Report for UDI Labeling Requirements

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