CDRH Seeks to Clarify UDI Requirements

By Jennifer D. Newberger –

On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.”  The purpose, according to the guidance, is to “provide[] clarification of key provisions of the UDI Rule.”  We previously posted on the UDI rule here.

Clarification, in this instance, appears to be little more than a regurgitation of information contained in the rule itself, the preamble to the rule, the UDI website, and the Global Unique Device Identification (GUDID) guidance document.  It is not clear what new insights FDA intended this guidance to impart.  There are parts of the rule that do deserve further clarification, but those issues are not addressed. 

For example, the definition of an implantable device is one that “is intended to remain implanted continuously for a period of 30 days or more.”  21 C.F.R. § 801.3.  By this definition, extended wear contact lenses are considered implantable devices, since they are intended to remain in the eye for 30 days.  Nevertheless, we assume that FDA did not intend to include extended wear contact lenses in the definition of an implantable device.  It would be helpful for FDA to clarify this point, but failed to do so in the FAQ.

Additionally, we have been made aware that many retailers may not be able to read automatic identification and data capture (AIDC) codes for a number of years.  All labels are required to contain a UDI in plain text and AIDC format.  For devices available over-the-counter at retail stores, it is not clear how the presence of a code in AIDC format will benefit the public health (e.g., by facilitating a recall) if the retailer is unable to read the code.  Even though FDA rejected an overall exception to UDI requirements for devices available at retail establishments, it would be helpful to industry for FDA to discuss situations in which a UPC code may suffice as a UDI until retail technology catches up to the AIDC requirement.  Until then, requiring companies to place AIDC codes on retail devices with UPC codes is burdensome with no countervailing public health benefit.

The title of this guidance document states that it is “Vol. 1,” implying that there will at least be a “Vol. 2.”  Hopefully, future UDI guidance documents will do more than repeat information that is already available.