What is a UDI and what do you need to know now?
There is much more to come from FDA by way of regulatory interpretation and we intend to track it.This is the first of a series covering our thoughts on the current Unique Device Identifier (UDI) program. We first provide a basic overview and then drill down a bit more in future installments, offering some practical insights along the way.
What is a UDI and what do you need to know now?
FDA’s Unique Device Identifier (UDI) is for medical devices and other related products (NOT drugs, since the pharmaceutical industry has their own specialized requirements). A UDI is designed to be a worldwide method of identifying and tracking your medical device.
The UDI rule was almost 10 years in development and was eventually mandated by Congress as part of the Food and Drug Administration Amendments Act (2007) Section 519(f) and the FDA Safety and Innovation Act (FDASIA) signed in 2012.
Every class (I, II, and III) of medical device including IVDs, software, some combination products, and tissue based (HCT/P) products regulated as a medical device must conform to the UDI rule’s specialized product identification labeling standards.
Compliance is going to be expensive and time consuming. FDA estimates the cost to the US medical device industry at approximately $100 million per year, which in our view is severely understated. The agency states in the final federal register rule, “Unique Device identification System; Final Rule” 78 FR 58785 dated September 24, 2013, that for small business “The final rule may have significant economic impact on a substantial number of small entities that label medical devices.”
What is the UDI, how do you go about getting one, and when do you need it?
The long and the short of the UDI is a unique labeling link to your company and your product by means of a special numeric or alphanumeric code. This code will contain product specific information that MUST identify the medical device offered for commercial sale. The UDI must be in human readable form and be suitable for automated identification data collection.
This regulation does not apply to internal or interplant product transfers between establishments of the same parent company, products under an approved IDE, or for foreign establishments that do not import or offer a specific medical device for US sale
Company compliance with the UDI rule is mandatory. Although FDA usually exercises discretion when enforcing new regulations, failure to comply with the UDI requirements could mean the product is considered misbranded under the Federal Food, Drug and Cosmetic Act and could result in a warning letter or other administrative action. We think the FDA will exercise leniency as everyone, FDA and industry, comes up to speed on how to implement this new law. But this leniency will not last forever.
Before we go further there are some new acronyms to remember and understand.
New FDA acronyms to remember:
DI = “Device Identifier”—An example of a DI is code that references the manufacturer, medical device model or version. It is fixed for a specific model or version. A DI will change with a new model or version.
PI = “Production Identifier”—This code number represents the specific lot number, serial number, manufacturing date, and/or expiration date of a device identified by the DI. Unlike the DI, the PI is variable.
AIDC = “Automatic Identification and Data Capture”—Technology that allows for the identification and collection of data contained in the UDI and storing it on a computer.
GUDID = “Global UDI Database”— A world wide database where your product’s UDI will be registered. To aid companies FDA has a draft guidance document in development.
The simplest way to explain a unique device identifier is the equation UDI = DI +PI. For a UDI to be valid both the DI and the PI must be present on the device labels.
The precise data requirements of a UDI will be defined by FDA. But a UDI is NOT the same as a universal product code (UPC). A product’s UDI will be specifically registered with FDA on their new web site. As with many aspects of the UDI, there are exceptions. For Class I devices a UPC may be suitable.
How do you obtain a UDI?
A UDI is NOT a code that is self-generated or invented by your company. A UDI code must be approved by the FDA and only companies that have received special FDA accreditation are allowed to issue UDIs that comply with the rule.
To date there are only three independent entities that FDA has accredited to develop and issue UDIs to the medical device industry.
1) GS1 is a large non-profit company established in 1974, international in scope, with expertise in product identification. They established the first readable and widely used UPC code system. (www.GS1.org)
2) Health Industry Business Community Council (HIBCC) is an ANSI-accredited organization, with its primary focus to facilitate electronic communications by developing appropriate standards for information exchange among health care trading partners. (www.HIBCC.org)
3) International Council for the Commonality in Blood Banking Automation (ICCBBA) is a non-profit company for enhancing patient safety by promoting and managing the ISBT 128 international information standard for use with medical products of human origin. The SBT 128 is a global standard for the identification, labeling, and information transfer of human blood, cell, tissue, and organ products across international borders and dissimilar health care systems. (www.ICCBBA.org)
When do you need to directly label your product with the UDI the “Compliance Date?”
In a nutshell: September 24, 2013 is the start date FDA uses to determine medical device UDI compliance. Compliance means medical products need to be labeled with a UDI. Different device classifications must have a UDI on or before the different dates, as set forth below:
Class III medical devices and human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device must be labeled with a UDI one year from the compliance date by September 24, 2014. [A one year extension of this date may be granted if submitted by June 23, 2014.]
Class II implants and life supporting/ sustaining devices must have a UDI by September 24, 2015.
Class II devices not included above by September 24, 2016.
Class I by September 24, 2018.