On September 24, 2013, the U.S. Food and Drug Administration (FDA) will release a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).
What is a UDI?
A UDI is a unique numeric or alphanumeric code on the device label and device package (and in some cases, on the device itself). A UDI consists of two parts:
- Device Identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler (company placing the UDI) and the specific version or model of a device, and
- Production Identifier (PI), which is a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- Lot or batch number within which a device was manufactured;
- Serial number of a specific device;
- Expiration date of a specific device;
- Date a specific device was manufactured;
- Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
The UDI must be provided in both plain text and machine readable format (e.g., barcode, RFID). FDA does not require a specific type of production identifier (e.g., lot vs. serial number) to be used. Manufacturers will establish their UDI code according to one of the allowable standards. The default location for the UDI is the device label and higher levels of packaging. Some devices are also required to be “direct marked” on the device itself. These are devices intended to be used more than once and which are reprocessed before each use (e.g., cleaned, disinfected or sterilized). Standalone software must also have a method of displaying the UDI (e.g., through the “About” menu).
UDI issuing agencies must apply to be accredited by FDA. Examples of UDI issuing agencies are GS1, HIBCC and ICCBBA.
Compliance with the UDI requirements depends on the device’s classification:
- Year 1 (September 24, 2014): Class III devices (and devices approved under the PHS requirements (BLA))
- Year 2 (September 24, 2015): Class II devices that are implants or life supporting/sustaining
- Year 3 (September 24, 2016): Remaining Class II devices
- Year 5 (September 24, 2018): Class I devices
FDA is providing an exception to the compliance dates for finished devices that have been manufactured and labeled prior to the UDI compliance date for that device. This exception would expire 3 years after the compliance date.
The compliance dates for the direct marking requirements (for those devices for which this is required) are September 24, 2015 for life supporting or life-sustaining devices, and 2 years after the compliance date for all other devices.
Exemptions from UDI Requirements
There are several exemptions from the UDI requirements, including:
- Class I devices do not need production identifiers (but the device identifier is required)
- GMP exempt Class I devices are exempt completely from the UDI requirements; however, the standardized date format requirement (see below) still applies
Global UDI Database (GUDID)
As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public.
Access to GUDID will initially be limited to Class III devices and devices approved under the PHS Act (BLA). Manufacturers with Class III devices are encouraged to submit their UDI information as early as possible.
Two methods will be available for submitting information to GUDID:
- Web interface
- HL7 SPL
Manufacturers will be required to submit device information to the GUDID for each device they market. Only static device identifiers will be required to be submitted to the GUDID, not the production identifiers. Information required to be submitted to GUDID includes:
- Trade/brand name of device
- Previous UDI identifier if a new version of existing model
- Version or model number
- If direct marked
- Size of the version or model
- Type of production identifiers on label
- Premarket submission and device listing numbers
- GMDN preferred term
- FDA product code
- # of individual devices in each package
- Commercial distribution status (still selling or no longer distributed)
- Higher levels of packaging
- Whether device is a kit, combination product or HCT/P
- Whether device is labeled as sterile or sterilize before use (and how)
- Whether device contains latex
- MR compatibility status (MR safe, conditional, unsafe) if device so labeled
- Whether Rx or OTC
A new device identifier is needed whenever a change to a device results in a new version or model or creates a new device package. There is no relationship between when a new UDI device identifier is needed and when a premarket submission is needed.
FDA has also issued Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry to give labelers an overview of the GUDID. This draft guidance is designed to help labelers prepare to submit information to the GUDID by describing key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions. Comments may be submitted electronically or by mail according to the directions contained in the draft guidance within 60 days of the Federal Register publication of the notice announcing its availability. FDA announced that they plan to issue a final guidance 1-2 months after the comment period ends.
Key Changes from Proposed Rule
- OTC (non-prescription or over-the-counter) devices are required to meet the UDI requirements. Exception: Class I OTC devices labeled with a UPC code may use the UPC code as the UDI.
- Combination products and convenience kits are required to have a UDI, however the device constituent part of that combination product or kit are exempt from the UDI requirement. If the combination product instead has an NDC code, it is exempt from the UDI requirements however in that case, the device constituent part must have the UDI unless the product is a single entity combination product where the drug/device are physically, chemically or otherwise combined.
- Direct marking is now only required for devices that are reusable device intended to be reprocessed before each use. There are provisions for exemptions from direct marking if the marking would affect device safety or effectiveness, if it is not technologically feasible, etc.
- The use of a special symbol as originally proposed is no longer required to indicate the presence of AIDC technology but the device label must disclose the presence of it.
- The UDI must include MR compatibility status (safe, conditional, unsafe) if the device is labeled this way.
Request for Exceptions
Manufacturers may apply for exceptions from the UDI requirements. FDA will post exceptions granted on its website and these exceptions will in turn apply to other manufacturers with devices meeting the same situations.
Standardized Date Format
In addition to the UDI requirements per se, all medical devices are now subject to standardized labeling date format requirements, which are different in the final rule compared to what FDA initially proposed. The standardized date format is now YYYY-MM-DD. For example, an expiration date of June 19, 2013 on a device label would be displayed as 2013-06-19. A day must be identified, not just the month and year. Another change from the proposed rule is that the standardized date format will have the same compliance dates as other UDI requirements (e.g., a Class II other than implant or life supporting/life sustaining device at 3 years), whereas the proposal required the standardized date requirements for all devices at 1 year. Devices not required to have a UDI will be required to implement the standardized date format at 5 years.
Other Impacted Regulations
Conforming amendments were also made to the MDR, Correction/Removal, Recall, PMA, Quality System Regulation, Device Tracking, and Postmarket Surveillance regulations. For example, an MDR report, Report of Correction or Removal, and PMA report will be required to include the UDI. The labeling inspection, DHR, complaint files and servicing requirements of the Quality System Regulation have been amended to include requirements for UDI. The Device Tracking requirements have also been amended to allow UDI to be tracked by device manufacturers and distributors