Requesting an Extension/Exception to the U.S. FDA UDI Rules

iStock_000011089235SmallerAre you behind in your preparations for the September 24, 2014 deadline for Unique Device Identification on class III medical devices (see “UDI Deadline For Class III Medical Devices Quickly Approaching”)?  Do you need to apply for an 1-year extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act?  Do you need to file an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device?  Do you need to continue using an existing National Health Related Item Code (NHRIC) or National Drug Code (NDC) Labeler Code that was assigned to you by the FDA in the past (see “UDI And The Approaching End Of The NDC”)?

If you answered “yes”, or, “Uh…I think so”, to any of the questions above, then you are in luck, but for some of these, you need to act quickly.  Last week, the U.S. FDA published a web page called “UDI Exceptions, Alternatives and Time Extensions”, that allows device manufacturers to submit an inquiry request for each of these concerns.  To be successful, pay close attention to the deadlines.

Application Deadline Extension /Exception
Not defined General exceptions from the requirement for the label of a device to bear a unique device identifier (§ 801.30)
Not defined Request for an exception from or alternative to a UDI requirement (§ 801.55)
June 23, 2014 Time extension for a class III medical device or a device licensed under the Public Health Service Act
September 24, 2014 Continued use of FDA labeler code (§ 801.57)

Once you submit an inquiry through the FDA’s web page, an FDA UDI Help Desk Analyst will respond to the contact person you specify.  The FDA did not identify specific deadlines for requesting general or specific exceptions.  For class III manufacturers, I’d treat the deadline as June 23 if I were you.  Class II and class I manufacturers probably have more time since their compliance deadlines are farther out in the future.  However, manufacturers of any class who wish to continue using an NHRIC or NDC Labeler Code issued by the FDA must make that request by September 24 of this year.

For all extensions and exceptions, be prepared to make your case, including which devices are involved, in follow-up communications with the FDA.  How likely are they to grant your request?  Hard to say.  Let me know how the process goes for you and I’ll pass on the experience anonymously for others to learn from.


Also, according to Jonathan Bretz last week in a LinkedIn discussion, the FDA has now updated/corrected their Global Unique Device Identification Database (GUDID) guidance document with previously missing information.  The updates are contained in Appendix B and C of “Global Unique Device Identification Database (GUDID)“.


Need help understanding your obligations under the UDI Final Rule?  Have questions?  There are a bunch of consultants out there who can help (myself included), and you can attend the UDI Workshop in Baltimore this weeks (see “Bringing UDI and the Global UDI Database to Life“).  Or, plan on attending the UDI Conference in Baltimore on October 28-29.  In either case, use “RX” in the “promotional code” field when you register and get $100 off of the rate.