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.
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 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.
Introduction
Introduction
