unique device identifier

Jan

2024

21 CFR Part 830: Unique Device Identification

The FDA requires certain medical devices to have a unique device identifier (UDI) that can be used to identify and track them throughout their distribution and use. A UDI is a code that consists of two parts: a device identifier (DI) and a production identifier (PI). The DI identifies the specific version or model of a device, and the PI identifies the unit of device production, such as the lot or batch number, the serial number, the expiration date, or the date of manufacture. The UDI must be displayed on the device label and package, and in some cases, on the device itself. The purpose is to improve patient safety by making device recalls and postmarket surveillance easier.

UDI Applies to Only a Subset of Devices

The UDI system applies to a subset of devices that are classified by the FDA according to their risk level (see 21 CFR Part 821 for the list of devices and compliance dates).

Issuing UDIs

The UDI must be issued by an FDA-accredited issuing agency, such as GS1, and conform to international standards for data structure and character set. The UDI must use only one DI per version or model of a device, and must not reuse a DI that has been previously assigned to another device.

Global Unique Device Identification Database (GUDID)

The FDA also maintains a Global Unique Device Identification Database (GUDID) that stores the UDI and other information about each device. The GUDID allows the public and health care professionals to access information about medical devices. The labeler of a device, which is usually the manufacturer, is responsible for electronically submitting the UDI and other information to the GUDID no later than the date the label is placed on the device, or the date the device is released for commercial distribution. The labeler must also update the GUDID if any information changes, or if a new DI is required for a device.

The information that must be submitted to the GUDID for each version or model of a device includes:

The labeler’s name and contact information, and the name of the issuing agency
The DI, and any previous DI that was assigned to the device
The device name, and the version or model number
Any applicable statements that indicate if the device is sterile, has a permanent marking of the DI, contains natural rubber latex, has safety issues if exposed to magnetic resonance, or has multiple sizes
The type of PI that is displayed on the device label
The premarket submission number, if any, that was assigned by the FDA
The FDA listing number that identifies the device
The Global Medical Device Nomenclature (GMDN) term or code that describes the device
The number of devices contained in each package

The FDA may grant a waiver or an exception from the UDI requirements for certain devices, or allow voluntary submission of UDI information for devices that are not subject to the requirements.

Significant Changes to Devices Require a New UDI

A new DI is required for a device if there is a change in the device’s specifications, performance, size, or composition that could affect its safety or effectiveness, or if there is a change in the device’s package or labeling. The labeler must notify the FDA of any changes that require a new DI, and update the GUDID accordingly.

Corrections to UDI Data

The FDA may review the GUDID data and request corrections or explanations from the labeler if the data is incorrect or misleading. The FDA may also delete or modify the data if necessary.

Records

The labeler must keep records of all UDIs and the relationship of prior and current DIs for each device, and retain the records for three years after the device is no longer marketed. The FDA may inspect the records and request copies as part of its regulatory oversight.

Dec

2023

21 CFR Part 821 Medical Device Tracking Requirements

The point medical device tracking regulation is make sure the FDA, manufacturers, distributors, and patients can track certain devices from the manufacturing to the patient. The main reasons to do this are:

to ensure we can locate, remove, or notify patients of dangerous or defective devices or serious risks to health.
to help the FDA and manufacturers to monitor the performance and safety of the devices and to identify and address any potential problems or issues.
to protects the rights and interests of the patients who have received the devices and ensures that they receive timely and accurate information and assistance.

Which devices are subject to tracking?

The tracking requirements apply to Class II or Class III devices that meet the following criteria:

The device failure is likely to have serious adverse health consequences. This means that the device failure could cause death, life-threatening injury, permanent impairment, or require medical or surgical intervention to prevent permanent harm.
The device is intended to be implanted in the human body for more than one year.
The device is life-supporting or life-sustaining and is used outside a device user facility. This includes devices such as ventilators, infusion pumps, and oxygen concentrators.

The FDA maintains a list of devices that require tracking on its website.

What are the responsibilities of manufacturers?

Manufacturers of tracked devices must comply with the following requirements:

Establish a procedure for tracking the device throughout its distribution. There must be a way to collect and record the following information:
- The name and address of the distributor, the date of shipment, the lot number, the serial number, and the expiration date of the device.
- The name and address of the device user facility, the licensed practitioner who implanted the device, or the patient who received the device.
- The date of implantation, if applicable, or the date of receipt by the patient.
- The status of the device, such as whether it is in use, explanted, returned, or disposed of.
Establish a quality assurance program that includes auditing to verify the accuracy and completeness of the tracking information. The audits must be conducted at least once a year and must include a representative sample of the tracked devices.
Provide the FDA with the tracking information upon request. The FDA may request the tracking information for any reason, such as to conduct a recall, to investigate a safety issue, or to monitor compliance. The manufacturer must provide the tracking information within 10 working days of the request, unless otherwise specified by the FDA.
Update the tracking information at least every six months for the useful life of the device. The useful life of the device is the expected duration of the device’s functionality, as determined by the manufacturer. The update must include any changes in the status or location of the device, as well as any corrections or additions to the tracking information.

What are the responsibilities of distributors?

Distributors of tracked devices must cooperate with the manufacturers and the FDA. They must:

Maintain records of the tracking information provided by the manufacturer. The records must include the information listed above, as well as the date of receipt and the date of shipment of the device, and records of individual patients the device was sold to.
Provide the manufacturer or the FDA with the tracking information upon request. The distributor must provide the tracking information within 10 working days of the request, unless otherwise specified by the manufacturer or the FDA.
Provide the patient or the implanting physician with the tracking information upon request. The distributor must provide the tracking information within 10 working days of the request, unless otherwise specified by the patient or the physician.