A distinct numeric or alphanumeric code called a Unique Device Identifier (UDI) is used to identify medical devices on the US market and other global markets.The FDA uses these specialized codes as part of its Unique Device Identification System to provide regulatory oversight, which is crucial.
The medical device industry as a whole must be built on the highest quality and safety standards.Even though it’s never something anyone wants to think about, it’s important to prepare for the worst.
Regulators want to make sure that the manufacturer addresses the problem and prevents it from happening again in dangerous situations like device malfunction, adverse events, and even product recalls.
That is precisely exact thing the FDA has finished with its impressive endeavors to lay out the Remarkable Gadget Identifier (UDI) Framework.
What is UDI exactly?The FDA’s requirements for UDI are what?What should US manufacturers know about the system’s current state and how to take advantage of it?Learn everything you need to know about UDI by reading on.
What exactly is an UDI (unique device identifier)?
UDI markings consider each and every gadget to be recognized all through assembling, conveyance, and use.The reason for this recognizable proof framework is to make a bound together public (and worldwide) language for the clinical gadget industry, no matter what an item’s related gamble, expected use, or characterization.
The UDI system improves traceability and enables FDA officials and manufacturers of medical devices to swiftly respond in the event that a particular device issue puts patient safety in jeopardy.
The UDI Rule: What is It?
Since the FDA Amendments Act was enacted in 2007, the US has been working on developing a UDI system.
The Unique Device Identification System Final Rule (UDI Rule) is now required by law for all medical devices sold in the United States, despite delays.
The following principles govern both the UDI Rule and the unique device identification system associated with it:
Section 614 of the Food and Drug Administration Safety and Innovation Act (FDASIA) and Section 519(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) According to the FDA, this UDI Rule provides a solution to address the following needs of medical device manufacturers:
Improve FDA safety communication’s focus and effectiveness by simplifying the integration of device use information into data systems, reducing medical errors, identifying medical devices with adverse events more quickly, developing solutions more quickly to reported issues, and expediting device recall resolution. Who are UDI labelers?
The FDA defines the term “labeler” as “any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.” The person(s) responsible for the UDI of a medical device is the labeler.
In most cases, the manufacturer of the medical device will act as the UDI labeler. However, the labeler role may also be assigned to a specification developer, a single-use device preprocessor. A convenience kit assembler in instances of resale and distribution by a third party.
What is the format of UDI?
In most cases, the UDI format adheres to a uniform marking system that includes the following:
ID of the device (DI):a mandatory, fixed section that specifies the device’s labeler and specific model or version. The DI number is assigned to new businesses by the Data Universal Numbering System (DUNS), which is managed by the UDI firm Dun & Bradstreet. It can be assigned within 30 days of a request.
PI: Production Identifiera variable portion that indicates one or more of the following:
The unique identification code required by 1271.290(c) for a human cell, tissue, or cellular. Tissue-based product (HCT/P) regulated as a device is the place of manufacture. The date of manufacture, the serial number, and the expiration date.
Unique identifiers are intended to be unique to only one device. As the name suggests.As a result, labels and packaging for single-use devices must all include UDIs.
Additionally, the UDI must be printed directly onto the device itself if it is intended for multiple uses.
Accessibility is also taken into account. The UDI Rule in the form of plain text that is simple to read. Machine-readable text that can be used with automatic identification and data capture (AIDC) technology.
Understanding the (Global Unique Device Identification Database) GUDID The UDI Rule laid the groundwork for the creation of the Global Unique Identification Database (GUDID), an administrative portal that catalogs each device with a unique UDI worldwide.In the United States, this database is required by law because it increases visibility for both the public and private sectors.
GUDID follows 21 CFR 830.310, which stipulates that electronic records must be kept. Submitted to the FDA, and only includes the DI portion of the UDI.
There are two strategies that can be utilized for GUDID entries:
structured input on the GUDID Web Interface that necessitates manual data entry.This approach is intended for submitters with low volumes.
Structured Product Labeling (SPL) at Health Level 7. This method of submission makes use of the FDA Electronic Submissions Gateway (ESG). Which is designed for high-volume submitters and supports XML file submission.
Keep in mind that the GUDID submission process frequently involves multiple roles. The guidelines say that any device can have multiple accounts. Outsource the documentation work to a third party that has been approved.
Even though the FDA gives organizations some leeway, each GUDID account should at least have:
One Regulatory Contact, One Labeler. One Coordinator It is important to note that the UDI labeler must include its certification. DUNS number in the submission. For those who choose to use the HL7 SPL submission option, the coordinator role is also optional.
Greenlight Guru:
How to Stay Compliant with UDI Requirements Adhering to UDI requirements. Is a crucial part of keeping your medical device safe and in compliance with regulations.
Medical device manufacturers can take advantage of the MDSP’s automation capabilities. Which generate all the information required to meet UDI requirements, with Greenlight Guru’s eQMS software.
In a closed-loop MDSP software that acts as your medical device’s single source of truth, you can securely store and access all quality system data pertaining to your UDI.
