Posted 25 June 2015
By Alexander Gaffney, RAC
New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI).
Under a final rule released in September 2013, most devices marketed in the US will eventually be required to be marked with a UDI—an identifying mark used to distinguish devices from one another and make them easier to track.
A UDI is composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
FDA's UDI rule was originally mandated by the Food and Drug Administration Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).
FDA's latest guidance—part of a series of guidance documents related to UDI—is focused on the process of actually "marking" a device with a UDI.
For some devices, such as durable medical equipment, the marking process is hypothetically simple: A mark could go almost anywhere on a wheelchair without affecting patient safety. But for some products, including implantable medical devices, the marking process could potentially be far more difficult. Even minor changes to a small, high-risk device have the potential to affect patient safety.
"As explained in the preamble of the UDI Rule, direct marking requirements apply to devices that are intended to be used for months or years, sometimes many years," FDA writes in its latest guidance document, Unique Device Identification -- Direct Marking of Devices. "Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages. Direct marking best assures the adequate identification of such devices."
For most new devices, the UDI marking requirements will require the company to design the UDI mark into the device. Companies will have flexibility to determine how the marking occurs as long as the mark contains all of the required information and is able to last the expected life of the device and survive reprocessing.
"Possible methods to directly mark a device with a UDI include etching, attaching a permanent plaque to durable equipment, or affixing a permanent tag such as a radio frequency identification (RFID) tag to the device," FDA wrote. "However, we do not specify any particular approach to directly mark devices, because it would be difficult to account for the wide variety of existing devices, use conditions, and reprocessing methods for these devices."
Devices already approved by FDA will have an extra three years to comply with UDI marking requirements, FDA said. If UDI changes could "significantly affect the safety or effectiveness of the device," companies will need to conduct an analysis of the UDI marking change. If the marking would cause such a "significant" impact, the company will need to submit a new 510(k), Premarket Application (PMA) or Biologic License Application (BLA).
The guidance also answers some frequently asked questions. For example, FDA confirms that, yes, the full UDI is required to be directly marked on the device. In addition, FDA notes that if the UDI on the device label changes, the direct mark on the device does not need to change.
Comments on the draft guidance will be accepted until 26 September 2015.
Unique Device Identification -- Direct Marking of Devices (FR)