What is UDI Submission?
The United States Food and Drug Administration (FDA) has established a unique device identification system (UDI) to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. A Unique Device Identification (UDI) system is intended to provide single, globally harmonized positive identification of medical devices through the distribution and use. This requires the label of devices to bear a globally unique device identifier
UDI systems typically use a combination of hardware and software to identify a particular device with a unique identifier. The identifier can be used by manufacturers or service providers to track how the device is being used, including any modifications made to it by third parties.
Who needs UDI Submission?
- Unique device identification system (UDI) submission is needed by all companies that manufacture or import devices in the United States. This includes manufacturers of pacemakers, hearing aids, implantable cardioverter-defibrillators (ICDs), insulin pumps and infusion sets, implantable drug-eluting stents, transdermal patches and iontophoresis systems.
- Any labellers and FDA-accredited issuing agency is required to comply with the UDI labelling submission.
- A device labeller is someone who causes a label to be applied to the device or the label to be modified with the intent of the device being commercially distributed.
- So, the device manufacturer and the labellers need to comply with their UDI submissions to the FDA.
What is the process of UDI Submission?
A Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following –
- Device identifier – a mandatory, fixed portion of a UDI to identify the labellers and the version of the device
- Production identifier – conditional variable portion of a UDI to identify one or more of the batch number, serial number, expiry date, manufacturing date, and distinct identification code of the device through its label
The FDA UDI Process is as follows:
- UDI is created through a new FDA UDI submission or by importing it from a spreadsheet.
- A user in the UDI Creator role receives a task to edit the UDI and edits the UDI data as needed.
- After the UDI Creator completes the edits and clicks Finish, the system validates the submission against published FDA UDI rules. The system then sends the UDI package to a user in the UDI Approver role.
- The UDI Approver opens the task and the attached report for review. After approval, the UDI advances to the next reviewer or the Submission state when complete. Reviewers approve the UDI using an e-signature.
- After the reviewer approves the UDI, the system submits the HL7 document to the FDA using the Electronic Submissions Gateway (ESG).
How can Perfect Pharmaceuticals Consultants help?
UDI submissions can be a confusing and frustrating process to navigate, especially if you’re new to the pharmaceutical industry. However, this process is crucial for making sure your products are safe and effective for consumers.
Perfect Pharmaceuticals Consultants is here to help you with your UDI submissions to the FDA. We have an experience of over 20 years in this field and can help you submit your UDI forms to the FDA hassle-free. Click on the <button> to allow us to your UDI for your medical devices.