UDI stands for Unique Device Identifier, or Identification, depending on how it’s used and, if you’re wondering whether or not the UDI compliance mandates brought into motion by the FDA in September of 2013 were magically going away or even changing any time soon; it’s not gonna happen! The premise on which the concept of a unique identifier is founded is far too important and far more complex than just having to label a medical device a certain way.
UDI is at the core of a much broader, comprehensive effort by the FDA’s Center for Devices and Radiological Health (CDRH), which in the simplest of terms is tasked with safeguarding patient care and improving the public health. As it relates to medical devices, the CDRH’s reach extends from premarket approval to how the devices are made, how they perform, and how safe they are. Such a massive undertaking could not succeed without having access to reliable, accurate, and timely information throughout a given medical device’s lifecycle, most importantly information related to what all patients’ cumulative experiences were while using a particular medical device.
In 2012, the FDA, through its CDRH, launched a collaborative effort to establish a national system under which data, lots of it, could be captured, stored, accumulated, analyzed and used by a broad range of stakeholders in both the public and private sectors. The National Medical Device Postmarket Surveillance System (MDS) was the result of that push and the adoption of a medical device unique identifier was deemed a mission-critical component of any wide-scale effort to protect and promote public health. That is why UDI is here to stay and why no medical device manufacturer should bank on the FDA making many, if any, changes to its UDI compliance mandates and deadlines.
In its broadest terms, the UDI universe is comprised of two basic components:
Labeling requirements that mandate the use of a Device Identifier (DI) and a Production Identifier (PI). The former is a static portion of a UDI label that identifies the labeler and the device model, while the latter represents the conditional variable portion of a UDI label that can be used to ID one of a number of attributes such as: a manufacturing lot or batch number, a unique serial number, the date manufactured, the expiration date, and the 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.
To facilitate the UDI system, the FDA has also created the Global Unique Device Identification Database (GUDID), which includes a standard set of basic identifying elements for each device bearing a UDI label. Most of this information is available to the public, which gives users of a medical device the opportunity to easily look up information about their device. GUDID contains only static information about medical devices and does not make available any information that identifies patients who have used a device or market intelligence facts such as the volume of units sold and shipped, distribution channel and end-user demographics, or pricing among other data.
The intent of this brief introduction is to address the origin and purpose of UDI. In following plain english contributions to this series, we will address in no particular order:
- who stands to benefit from UDI implementation
- what the two acceptable UDI standards are and who regulates them
- why it’s important to get started early, even if mandated FDA deadlines are seemingly far into the future
- what steps need to be taken prior to even considering how GUDID submissions will be formulated and uploaded
- why it’s important to do all of this in a manner that will allow a medical device manufacturer to input data that can be recalled and modified without having to navigate through a maze of spreadsheets
- the challenges to applying labels that will survive a medical device’s product lifespan.
UDI Compliance Solutions (UCS) is not affiliated with any government agency and we’ve created udiforum.com where you are welcome to make comments, ask questions, and request more detailed information to that which is being presented in this current series of posts. If you are further along the way to becoming UDI compliant than what will be covered here, we at UCS will be more than happy to provide any assistance you may require.