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:
- 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.
- 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.
- 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.
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.
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.
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.
What is a Class 1 Medical Device?
A Class 1 medical device is a device that has not been shown to present risks beyond those associated with the basic safety and performance characteristics generally accepted for non-medical products. Examples of Class 1 medical devices include wheelchairs, tooth-cleaning kits, and hearing aids. Some Class 1 medical devices are exempt from regulatory requirements set out by the FDA.
What are the Regulations for Class 1 Medical Devices?
Class 1 medical devices, while exempt from most FDA regulations, must still comply with essential principles of safety and performance. This means that manufacturers of Class 1 devices must demonstrate compliance with controls in the US and international standards of good manufacturing practice (GMP). Manufacturers of Class 1 medical devices must also ensure that their products are labeled appropriately, including a description of the device’s intended use, pertinent warnings, and instructions for use.
What Documentation is Required to Manufacture a Class 1 Medical Device?
For Class 1 medical devices, the manufacturer must create a device master record (DMR) including documents such as design drawings and specifications, materials used in device production, processes used to manufacture the device, an identification of all parts of the product and their functions, instructions for use and storage, a description of the testing procedures performed during production, along with results documentation. In addition, manufacturers must also document records that demonstrate compliance with quality systems requirements.
How Does a Company Ensure its Class 1 Medical Devices Meet Quality Standards?
To ensure that their Class 1 medical devices meet quality standards, manufacturers must adhere to the Quality System Regulation (QSR). This requires companies to develop and implement a robust quality system that meets the requirements specified in the QSR.
The QSR outlines specific design control, production and process control, inspection or verification, nonconforming product evaluation, and corrective and preventive action processes. By following these regulations, manufacturers can ensure that their medical devices meet safety standards before bringing them to market.
FDA UDI Requirements for Class 1 Medical Devices
The FDA classifies devices into 3 classes: 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.
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.
What is the GUDID Database?
The GUDID (Global Unique Device Identification Database) is an essential tool for both healthcare providers and manufacturers of medical devices. This database allows manufacturers to register device information and provides up-to-date access to healthcare professionals to ensure the safety, quality, and effectiveness of the products they use.
The GUDID is managed by the U.S. Food and Drug Administration (FDA) and is a secure, centralized repository decentralized of device identification information submitted by medical device manufacturers. This data is updated regularly to ensure accuracy, traceability, and readability, which helps healthcare providers make informed decisions about their device selection and use. Also, by submitting device information to the GUDID, medical device manufacturers can comply with FDA regulations.
How can the GUDID database help you?
Making full use of the GUDID database can have many advantages for both medical device manufacturers and healthcare providers. For example, the unique identifier provided by GUDID makes it possible to identify a device with accuracy, traceability, and readability information. Additionally, GUDID data provides healthcare providers with essential guidance for usage and disposal instructions for medical devices at the end of their profile information. Furthermore, medical device manufacturers can also benefit from access to timely updates on any changes made to their devices’ profiles or FDA-regulated recall status.
How to Search the GUDID Database?
The GUDID database makes it easy to quickly lookup a device. All you need is either the name of the device or its Universal Product Code (UPC). You can find the UPC on or near the product’s packaging. Once you have identified the product, click on it in the GUDID search results to access information such as medical device descriptions and instructions, actions performed by the manufacturer, and any known recalls related to that particular item.
How to Optimize the Performance in the GUDID Database?
You can easily optimize your performance in the GUDID database by learning how to use its most helpful features. To create accurate, up-to-date device information, you’ll want to take advantage of GUDID’s bulk submission capabilities, label augmentation services, and report tracking tools. Additionally, it’s important to remain vigilant about managing data accuracy – always double-check prior submissions and confirm current device versions are accurately listed within the system.
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).
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 obtaining 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.
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 to 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 (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: