FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023

Introduction:

FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand overview, you’ll gain insight into the prerequisites for device categories, UDI labeling requirements, and more.

With the proliferation of medical devices worldwide, it is important to stay on top of applicable UDI labeling requirements. This guide will explain the global regulatory standards for Unique Device Identifiers (UDIs) and other important information about UDI labeling and usage.

The FDA UDI Database is a powerful resource for medical device manufacturers, regulators, health care providers, and patients. With its comprehensive collection of unique device identifiers (UDIs) and associated data, the FDA UDI Database simplifies product tracking, regulatory compliance, patient safety, and post-market surveillance. Learn how to make the most of this invaluable tool with our guide on navigating the FDA UDI Database.

FDA and UNDI Requirements:

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.

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.

Overview of Class 1 Medical Device FDA Regulations:

1. Know Your Pre-Market Requirements-  Before you can even start the market entry process for a Class 1 medical device, you must have the right prerequisites in place. These include confirming the product is in an appropriate category (such as general or hospital use) and understanding the labeling requirements of your product before submitting it. Additionally, if you’re using third-party test results, they must be approved by FDA personnel before they’re submitted with your device application.
2. Understand the Proper Labeling Requirements- Labeling is a big part of class 1 device market entry. You must include the information required by FDA so consumers can understand how to use your product safely and effectively. This includes basic information such as the product name, intended purpose, hardware components, and identification/serial numbers. Additionally, you may be required to provide prominent health hazard warnings depending on the use of your product. It’s important to pay attention to these labeling requirements when preparing for a Class 1 device submission.
3. Research Ban Laws & Rules in Your State- Before entering the Class 1 device market, you should research the laws and regulations set by the FDA in your state. You should also become familiar with any unique requirements that may apply to your device type. Additionally, be sure to read up on pre-market requirements for medical device manufacturers operating out of different states as these will differ. Understanding your FDA state-specific requirements is essential when planning a successful Class 1 medical device submission.

4. Ensure Compliance with Quality Systems Regulations (QSR)- All FDA-regulated manufacturers must comply with the Quality System Regulation (QSR), which is comprised of 21 CFR 820, by developing and maintaining an effective quality system that describes how you will comply with requirements. The QSR includes the establishment and maintenance of a system for design control, including established design specifications and accurate record-keeping. When planning your product launch, ensure that all documentation meets QSR requirements to avoid costly delays or rejection from the FDA when making a registration or listing submissions.

5.  Determine If FDA 510(k) Clearance Is Necessary- Before embarking on the Class I medical device FDA regulatory pathway, consult with the FDA to determine if 510(k) clearance is needed. Most Class I devices are exempt from premarket notification (510(k)) unless they are listed in a class II or III device classification. Determine whether any of your product’s intended uses or technological characteristics cross over into the parameters of higher-risk categories, and update your device’s labeling accordingly.

Understand Global UDI Regulations:

Understanding the global UDI regulations will help with compliance and ensure that your medical devices are properly labeled. Regulations differ from region to region, so it is important to familiarize yourself with the applicable rules which may include labeling requirements, a timeline of implementation deadlines, and registration systems for reporting UIDs. In addition, depending on jurisdictions like the United States Food & Drug Administration (FDA), there may be further stipulations or exceptions specific to your region.

What is the FDA UDI Database?

The FDA UDI Database is a comprehensive online system maintained by the US Food and Drug Administration (FDA) that houses the complete list of all UDIs and associated data. Manufacturers are required to submit information about their medical device products such as model numbers, product codes, expiration dates, and serial numbers to the database to receive marketing authorization. This data is then available for retrieval by healthcare providers, regulators, and patients anywhere in the world.

Understanding the UDI System and its Key Components:

The FDA Universal Device Identification (UDI) System is the foundation of the UDI Database and plays a vital role in collecting the necessary data on medical device products. UDI system components include the labeler code(i.e., manufacturer or distributor), the product code, and a unique serial number for each medical device product. These three components combine to form a complete UDI that is printed on the device’s labels and/or packaging, which can then be scanned to access information about it from the database.

Exploring the FDA UDI Database and its Features:

The FDA UDI database is designed to provide businesses and healthcare professionals with easily accessible information about medical devices. It allows users to search the database by manufacturer, product name and code, device risk classes, or other criteria such as expiration dates. Additionally, the database offers a variety of features that allow businesses to create customized reports and barcodes for selected devices. Several safety alerts may be triggered when certain conditions are met. This ensures that healthcare professionals and consumers have up-to-date information regarding the performance of medical devices.

Tips for Optimizing Your Search in the FDA UDI Website:

To optimize your search on the FDA UDI website, you should consider narrowing down your search criteria by using specific keywords or phrases. Try to focus on terms and concepts that are related to the medical device you are looking for. Additionally, it is helpful to use Boolean operators such as “AND”, “OR”, and “NOT” when conducting searches in the FDA UDI database. Boolean operators allow users to create more targeted searches by combining multiple keyword phrases together.

Finding Resources for Navigating the FDA UDI Database Quickly and Efficiently:

In addition to Boolean operators, the FDA UDI website provides valuable resources for navigating the database quickly and efficiently. First, verify that you are looking for the correct device class. The FDA categorizes devices into three main classes; Class I (low risk), Class II (moderate risk), and Class III (high risk). Knowing which device class your device is classified under will assist with the narrowing of your search. Other helping search criteria include searching by brand name, product code, or identifying number.

Label All Products With UDI Markings:

One key requirement of UDI and UID systems is the label marking system for products. Different countries may have different standards and formatting for label markings, but the basics remain the same: all products must have a plain-text label marking with at least one basic data element (e.g., trade name, product identifier) along with the UDI notation in either human- or machine-readable format.

What is the FDA Unique Device Identification (UDI) system?

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 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.