On September 24, 2013, the UDI rule otherwise known as the Unique Device Identification system was published by the Food and Drug Administration (FDA). The system was set up to more effectively and efficiently identify medical devices sold in the United States throughout the manufacturing journey to distribution and use.
The goal of the new UDI system is to enhance the safety of patients, modernize post-market surveillance of devices and facilitate innovation in medical devices. Under the new rules device labelers will have to:
- Include a UDI on device packages and labels except if an alternative or exception is allowed by the new rules.
- If a device has more than one use and will be reprocessed before its next use case, the device labeler is required to mark the UDI directly on the device.
- Submit the information about each device to the Global Unique Device Identification Database (GUDID).
While the UDI rule followed a phased approach in GUDID submission requirements and labeling based on device risk, all classified and unclassified devices are now expected to comply with the new regulations except for devices not subject to or expressly exempted from UDI labeling requirements.
Importers can usually search the GUDID database using AccessGUDID through which they can:
- Search for devices by device identifier, company, or device name
- Use a combination of fields in the database to conduct advanced searches
- Export and download GUDID search results and data
Technical Requirements of a UDI
The UDI system is founded on international regulatory cooperation activities and hence draws from internationally recognized standards about data exchange and unique identification. According to the rule, each UDI must include the following:
- A device identifier that has to correspond to the specific model or version of the machine and labeler of the device ( in most instances the labeler is the manufacturer but he may be a single-use device reprocessor, a specification developer, a relabeler, a repackager, or a convenience kit assembler).
- A production identifier that precisely identifies the particular device through variable information such as date of manufacture, batch or lot, expiration date, serial number, and different identification codes for tissues, human cells, or tissue and cellular-based products.
A device labeler is required to provide the UDI in two forms on packages and labels:
- A machine-readable format that makes use of automatic identification and data capture (AIDC) technology
- Easily readable plain text
To develop a UDI, labelers may use one of the FDA-accredited issuing agencies.
Benefits of the Unique Device Identification System
The new UDI rules are intended to substantially reduce obstacles to the effective identification of medical devices in the US. They make it possible to definitively and rapidly identify a device and the critical attributes that affect its effective and safe use.
The critical benefits of the UDI system are that it intends to:
- Reduce medical errors – By having a UDI with device information in the GUDID there will be accurate and rapid identification of devices which will eliminate confusion that could result in inappropriate use of medical devices.
- Simplify the integration of device-use information into data systems – When paired with AIDC technology will make it possible for physicians to get access to accurate data on medical devices which can be easily recorded and retrieved.
- Make it possible for rapid identification of Medical devices with adverse events – The inclusion of UDIs in adverse event reports would promote the timely resolution of adverse events as there would be greater accuracy in reporting thus eliminating uncertainty in the identity of medical devices used.
- Rapid Solutions to reported problems – The FDA and manufacturers can more rapidly aggregate, review and analyze related reports concerning a particular device to isolate and identify underlying problems and find solutions.
- Rapid and efficient resolution of recalls on devices – Devices labeled with a UDI can be easily tracked down during a recall thus reducing or eliminating the risk of continued use on patients.
- More effective and better-focused FDA safety communication – using UDIs the FDA will be better able to focus health notifications, safety alerts, and other communications thus allowing more rapid response action and eliminating confusion with similar devices.
- The FDA anticipates that providers will include the UDIs of a wide range of devices in the Personal Health Records and Electronic Health Records of patients which will help with post-market surveillance of medical implant devices.
Refusal at the Port of Entry for Violations
Medical devices that arrive at the port of entry without a UDI on the label or/and a matching GUDID record could be refused entry at the entry point.
In instances where a product is refused entry due to a violation of FDA regulations and laws, the importer of record may apply to the FDA asking permission to recondition or re-label the product so that it can comply.
Steps of the Reconditioning Process
- Submission of From FDA 766 – This is submitted by the importer of record to the compliance officer listed on the Notice of FDA Action. The form should be submitted to the FDA through the Import Trade Auxilliary Communication System (ITACS) or the FAX, postal address, or email address of the local import division.
- Review of the proposal by the FDA which may deny or grant the proposal. The FDA may deny a reconditioning application if it does not have confidence that the product will be made compliant. If an application is denied, the importer of record will get a Notice of FDA Action from the compliance officer. The notice will also indicate if the importer may make another application for reconditioning.
- Completion of the reconditioning – If the application is approved it must be completed within a set time frame after which the importer will be required to notify the FDA that the imported devices are ready for examination.
- Verification of reconditioning – The FDA will conduct the verification at the expense of the importer to ensure the reconditioning complies with the laws and regulations. Once reconditioning is verified the product will be released but if not the product may be refused entry.
Frequently Asked Questions
- What Happens if Reconditioning is not successful?
If reconditioning is not successful, the importer may submit a second application. However, it is important to note that the second application will only be approved if meaningful changes have been made in the reconditioning operation. Typically importers will not be allowed a third attempt at reconditioning.
- What Happens if an importer cannot recondition the entire shipment?
The FDA may issue a partial refusal/partial release if part of the shipment has been successfully reconditioned. The FDA will usually issue a Notice of FDA Action for the part of the shipment that can be released following a successful reconditioning. The notice will also identify the part that was not in compliance and which has been refused entry.
- Who pays the costs for the reconditioning?
The importer of record who submits Form FDA 766 will pay all supervisory costs. These may include but are not limited to services of the FDA analyst if required, expenses for the FDA supervising officer, services of the FDA supervising officer, and per diem for the FDA supervising officer if working away from their home station.
- What changes would require a new device identifier?
Whenever a change is made to a device that requires it to have a unique device identifier on the label and the change results in a new model or version you will have to assign a new device identification to the new model or version.
