Global Regulatory Pulse

Upcoming UDI Requirements and 2016 Compliance Dates for Labelers of Class II Medical Devices

In FDA, Regulatory by Kristy Katzenmeyer-Pleuss

In 2013, the U.S. Food and Drug Administration (FDA) issued a final rule for a Unique Device Identification System to enable the rapid and accurate identification of medical devices throughout their distribution and use.

Once fully implemented, FDA states that the system will aid in accurate reporting and analysis of adverse events, reduce medical errors, allow more effective management of device recalls, help address counterfeit devices, facilitate integration of device use information into data systems such as electronic health records, and standardize the date formats used on device labels in order to minimize confusion.
There are several important requirements of the rule medical device labelers should be aware of—these are described below.  It should be noted here that FDA’s rule applies to device labelers, which are most often the device manufacturer, but may also be contract manufacturers, single-use device reprocessors, private label distributors, convenience kit assemblers, or other repackagers or relabelers.
  1. Medical device labels and packages and, in some instances, the device itself must include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.  The UDI must be provided in both a human-readable plain text format (e.g., numeric or alphanumeric code) as well as a machine-readable format (e.g., bar code or radiofrequency identification).  The UDI must also be directly marked on the device itself for reusable devices intended to be reprocessed before each use; this is to allow device identification in the situation where the device has been separated from its label and package.  The UDI is to consist of two separate identifiers: a device identifier (DI) and a production identifier (PI).  The DI is a portion of the UDI that identifies the fixed or non-variable information related to the device (e.g., the labeler and the specific device version or model), while the PI is a portion of a UDI that identifies the variable information related to the device also normally found on the device label (e.g., lot, batch, and serial numbers; expiration date; date of manufacture).  Device labelers are to use an FDA-accredited issuing agency to build their UDI.
  2. Dates used on medical device labels must be formatted numerically as YYYY-MM-DD, which represents the four-digit year, followed by the two-digit month, followed by the two-digit day, each separated by a hyphen.
  3. Product information found in the DI part of the UDI must also be submitted to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative.  Information found in the PI part of the UDI is not submitted to the GUDID.  In order to submit information to the GUDID, labelers will need to request a GUDID account.  Account requests from labelers of class II medical device opened February 1, 2016.  GUDID information can also be accessed by the public through the AccessGUDID database; this may be particularly useful for healthcare workers that want access to device characteristics for clinical decision support (e.g., MRI safety information, latex presence, device sterility status).
FDA is utilizing a phased approach to the rule’s compliance dates, which span over a period of seven years.  September 24, 2016, marks the date when labelers of class II medical devices, including stand-alone software, should be in compliance with the UDI requirements.  In the case where stand-alone software is not distributed in packaged form, the labeler would only need to comply with the requirements under § 801.50(b) of the rule.  Permanent marking of reusable class II devices intended to be reprocessed before each use must be complete prior to September 24, 2018.
Labelers can request an exception or alternative to the UDI requirements; for example, if the requirements are not technologically feasible or “an alternative would provide for more accurate, precise, or rapid device identification…or would better ensure the safety or effectiveness of the device that would be subject to the alternative”.  Labelers can also request permission for time extensions.    Devices listed under § 801.30 of the rule are not required to bear a UDI.
For additional resources, labelers can refer to FDA’s UDI Resources page for links to UDI guidance documents, webinars, and frequently asked questions.  FDA has also initiated a UDI Help Desk for submission of questions and comments related to the UDI program, which has a claimed response time of 2-3 weeks.
Authors:

Kristy Katzenmeyer-Pleuss, Ph.D, is a former FDA medical device reviewer and currently a Senior Medical Research Manager, Regulatory at NAMSA. She holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. Her experience includes developing high-level regulatory strategy and policy, facilitating communications and meetings with regulatory agencies, and drafting premarket submissions and deficiency responses. Kristy has experience with a variety of medical device types and combination products, including general and plastic surgery, wound care, dermatologic, cardiovascular, orthopedic, neural, ophthalmic, ENT, dental, respiratory, infection control, general hospital, digital health, etc. She is also a subject matter expert in biocompatibility and reprocessing (reusable and reprocessed single-use devices).