As a medical device manufacturer, you need to be aware of the FDA’s UDI rule, and know what you need to do to comply. Simply put, the FDA rule, proposed in July 2012, requires medical device manufacturers to label their products with a unique device identifier, or UDI. The purpose of the UDI is to improve identification and tracking for better recall management, protect against counterfeiting and diversion, and establish standards for a global medical device ID system.
Are you ready for UDI?
What Is a UDI?
The UDI code is a unique numeric or alphanumeric code that includes two parts: a device identifier (DI), which is specific to a device model, and a production identifier (PI), which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
The FDA does not specify which type of AIDC technology you must use and will accept identifiers that are part of the ISO 15459 series of standards. Therefore, you can use GS1 linear or 2D data matrix barcodes, or the HIBICC barcode, or RFID technology. The UDI must also appear on the label in a human readable format.
Manufacturers will then be responsible for submitting the device data to the FDA Global UDI Database (GUDID) and update that data when necessary. Information required includes data such as the manufacturer and contact information, a version number of the device, if the device is labeled as sterile, etc. The data will be made available to the public so that users of a medical device can easily look up information about the device.
The FDA defined a phased in approach to compliance depending upon the device’s risk classification:
- Class III devices, such as implantable pacemakers, must comply with the new rule within a year of final passing
- Implantable devices that are life-sustaining or life-supporting that are not Class III devices must comply within two years
- Class II devices, medium risk products like infusion pumps, must comply within three years
- Class I devices, low risk products like hand-held surgical instruments, must comply within five years
What Do I Do Now?
Identify which of your devices must come into compliance right now. Once the final rule is made, if you do not have a UDI system in place within the timeline specified by the FDA, you will not be able to sell your product.
Select a standard. Are you going with a GS1 GTIN, or will you use HIBCC barcode? The FDA does not mandate which auto ID carrier to use, but consider your customers. Not all healthcare providers have the capabilities to handle all of the different carriers. Select the appropriate standard and technology for your product and customers.
Determine how to label your products. You might be able to use a label, or you might need direct part marking. If you use a label, you must consider the label properties to ensure the data is scannable (proper ink and paper combination,) and be able to print variable data on your labels (expiration dates, for example.) You will need enough space on your label for the UDI requirements, such as the codes and artwork.
The following products require direct part marking:
- An implantable device, which by definition is intended to be used for at least 30 days
- A device that is intended to be used more than once and that is intended to be sterilized before each use
- Stand-alone software that is a “device”
Examine your packaging. The FDA requires a unique UDI at each unit of measure. So each individual product has its own UDI, as would the same product in a box of 12 and in a case of 12 boxes.
Examine your operational processes. You might need to add or change your current procedures to handle UDI tracking. Identify the data that will populate the UDI fields, such are serial numbers, expiration dates, etc. You will also need to establish how to maintain this information and who will be responsible for it.
If you are facing UDI compliance, you can look to us for your labeling and tracking requirements. We have helped some of our medical device customers with implementing GS1 or HIBCC barcoding, and we can help your company as well. We have durable pressure-sensitive labels, label printers, GS1 and HIBCC label templates for BarTender, barcode scanners, and other products to get you on your way to UDI compliance.
Give us a call at 603-598-1553 x237 and let us help you get started.
Update: the UDI Rule is finally to be released on September 24th 2013. You can see the pre-publication document here