FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part Two
Additional information on FDA’s guidance document is available in our preceding FDA News article, entitled “FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part One.”
On September 24, 2013, FDA published the UDI Rule, establishing a standardized identification system for medical devices that are used in the United States. According to this rule, the device label and all device packaging of every medical device distributed in the US would be required to bear a unique device identifier (UDI). With this rule, FDA’s goal was to create a unique system that would make it possible to quickly and accurately identify a device and some of the key attributes affecting its safe and effective use.
The UDI Rule includes a number of provisions, which the FDA has decided to implement in various phases over a seven-year time period. After receiving feedback from many concerned stakeholders regarding the deadline for some of these provisions, FDA announced this week that it does not intend to enforce its deadline for certain UDI provisions. The final guidance document, entitled “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices,” was published on Tuesday, August 30th and provides further details on the implementation of some of the UDI Rule’s provisions.
Dates for Removal of NHRIC & NDC Numbers
Finished devices that are manufactured and labeled before September 24, 2021 will not be subject to FDA’s regulations regarding the removal of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers. As such, the enforcement policy that FDA outlines in its guidance “applies to the requirement that labelers no longer provide an NHRIC or NDC number on a device label or device package as of the dates specified under 21 CFR 801.57(a)-(b); it does not extend to any of the other requirements under the UDI Rule.”
Because FDA’s UDI requirements are being implemented over time, some device labels will bear UDIs and others will include different types of identifiers. FDA’s intent is for its enforcement policy to facilitate a consistent date by which all medical devices will have legacy NHRIC and NDC numbers removed, making this transition more predictable.
Continued Use of FDA Labeler Codes
According to 21 CFR 801.57(c), labelers may request permission to continue using a previously assigned FDA labeler code under a system for the issuance of UDIs. Moreover, FDA states that “a labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs provided that such use is consistent with the framework of the issuing agency that operates that system and that the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code.”
According to 21 CFR 801.57(c)(2), the deadline to submit these requests was September 24, 2014; however, the guidance document notes that FDA will consider requests that are submitted until September 24, 2021. Additionally, the Agency will not take action against labelers who incorporate a previously assigned labeler code into their UDIs without requesting approval, provided an otherwise compliant request is submitted by September 24, 2021.
Compliance Dates for UDI Implementation
|Device||Label/GUDID/Date Format||Direct Mark (When Required)|
Class III (including Humanitarian Use Devices and class III I/LS/LS)
Devices licensed under the PHS Act
|September 24, 2014||LS/LS Class III devices must be directly marked by September 24, 2015
All other class III devices must be directly marked by September 24, 2016
|Implantable (class II, class I, and unclassified)||September 24, 2015||N/A|
|LS/LS (class II, class I, & unclassified)||September 24, 2015||September 24, 2015|
|Class II||September 24, 2016||September 24, 2018|
|Class I or unclassified||September 24, 2018||September 24, 2020|
Interested in learning more about the Agency’s implementation of the UDI Rule? View our preceding FDA News Article, entitled “FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part One,” or FDA’s full guidance document.