FDA UDI Requirements Update for Class 1 Medical Devices

FDA UDI Requirements Update for Class 1 Medical Devices

 

The FDA in July 2022 updated its guidance documents on Unique Device Identifier requirements (UDI). That guidance document now reflects the Global Unique Device Identification Database (GUDID) submission requirements for select class 1 medical devices.  FDA considers these products to be classified as consumer health products and therefore doesn’t enforce GUDID requirements for these medical devices when their labels must have a UDI.

FDA UDI Requirements Class 1 Medical Devices

Class I devices that FDA does not consider to be consumer health which is typically used in healthcare settings and are often subject to additional regulatory controls, such as the requirement to submit a premarket notification. For these devices, FDA has determined that submission of UDI data into GUDID is required as submission of UDI data into GUDID for these devices may also help reduce medical errors and simplify the integration of device use information into data systems.

The FDA’s Unique Device Identification (UDI) system is a critical component of the Federal Drug and Cosmetic Act (FD&C Act). The purpose of the UDI system is to provide a way for any person or business that manufactures or imports devices to identify each device they make, import, or offer for sale. This identification provides public health officials with crucial information about the device, which helps them track potentially harmful devices and make sure that approved devices are safe.

The FDA has historically required all Class 1 devices to be labeled with a UDI but recently expanded its requirements to include all Class 2-6 devices as well. This article will discuss how this requirement works in practice and what you need to do as an importer or manufacturer in order to comply with these new regulations.

The UDI System

The UDI System is a unique identification system for medical devices. The UDI consists of two parts:

  • A Device Identifier (DI) (a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device)
  • A Production Identifier (PI):  a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
    • Lot or batch number within which a device was manufactured
    • Serial number of a specific device
    • Expiration date of a specific device
    • Date a specific device was manufactured;
    • Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The device labeler must provide the UDI in two forms on labels and packages:

  • Easily readable plain text
  • Machine-readable form that uses automatic identification and data capture (AIDC) technology.

To develop a UDI, device labelers must contact one of the issuing agencies accredited by the FDA. Contact an FDA-Accredited Issuing Agency for details.

When are the UDI Rule requirements?

According to the medical device categorization, the FDA published a final rule in September 2013 establishing the UDI system.  The rule included compliance dates ranging from September 24, 2014, to September 24, 2020.

The UDI rule mentioned the following requirements:

  • Unless an exception or alternate is applicable, a device must have a UDI on its label and packing.
  • Stand-alone software that is governed as a device requires special labelling.
  • GUDID, the FDA’s repository for device safety information, requires data submission regarding any device that must have a UDI.
  • Specific dates must follow a defined format on device labels.

 

UDI Database Requirements:

The FDA requires that class 1 medical devices which are typically used in healthcare settings bear the UDI on their packaging. This is a 12-digit number that is a combination of DI and PI. . Manufacturers must register with the FDA by submitting information about the company name, location, contact information, etc., to get an authorization code that will allow them to submit UDI information for their own devices or those made by third parties.

The manufacturer generates this unique code when they register with the FDA and then uses it each time they submit data about medical devices through their system; this means there can be multiple codes associated with each device if it changes hands between manufacturers or is exported from one country into another.

Submitting Information to the Global Unique Device Identification Database (GUDID):

Device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID). GUDID includes a standard set of basic identifying elements for each device with a UDI and contains ONLY the device identifier (DI), which serves as the key to obtain device information in the database. GUDID does not include the production identifier (PI).

To submit information to GUDID, the device labeler must first request a GUDID account.

FDA UDI Requirements for Class 1 Medical Devices

The FDA classifies devices in 3 class: Class I, II, and III. These classifications allow the FDA to determine how much risk a product poses and how heavily it should be regulated. You can read more about each.

In general, the UDI submission requirements are different between these categories because they are considered to have different risk levels (i.e., higher for Class III). However, there are some similarities in their requirements as well: Namely, all devices must be registered in GUDID at least 30 days before distribution begins to avoid noncompliance penalties from the FDA after submitting your UDI information through MDRx.

GUDID Submission Timelines

The GUDID submission timeline and process have been designed to ensure that the UDI is assigned within 12 hours of the time of submission and that a labeler has access to all relevant information in one place at all times.

The steps are as follows:

  • Submit your device record (DR) or modification to FDA’s Global Unique Device Identification Database (GUDID).
  • Within 12 hours after submitting your DR/modification, check the status of your DR/modification on the GUDID portal and review any errors reported by FDA for resolution. Once resolved, please upload your corrected version of your DR/modification. If no corrections are needed, proceed directly to Step 4 below: Labeler Notification Reassignment Letter (LRARL) generation.
  • Upon successful completion of these activities outlined above, you will receive an LRARL from FDA via email with instructions for downloading labels from our CDRH Labeling Information Management System website—the same site where labels were previously downloaded using CDRH’s legacy Labeling Information Management System (LIMS).

Understanding FDA UDI Requirements is a great start to making sure you are fully compliant with medical device regulations.

By now, you’ve probably been bombarded with UDI requirements for class 1 medical devices and perhaps even class 3 devices. The GUDID submission deadlines are fast approaching, so it is important to understand what the FDA UDI requirements are for each type of product.

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) which required that every device include a unique device identifier or UDI. This act was created after years of poorly managed recalls and devices being used in procedures without any knowledge about their safety record. It was designed to increase transparency between healthcare providers and manufacturers by providing better information about the safety of medical devices that are being used on patients.

Conclusion

The UDI system is a great way to make sure that medical devices are properly tracked and identified. It helps ensure that they are not misbranded or adulterated, which could lead to serious harm or injury for patients. The FDA has made it clear that all Class 1 Medical Devices must be registered before being sold in the US. You should always be aware of your responsibility as a manufacturer when dealing with UDI requirements for any class of device, as well as understand how FDA UDI regulations apply specifically for each class level.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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