The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices. Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is delaying compliance dates for implantation of the UDI Rule for Class I and Unclassified devices by two years. Industry was notified of the Agency’s plan to delay last summer via letter, and this enforcement discretion policy has now been formally documented in FDA’s Immediately in Effect Guidance for Industry and FDA Staff, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” issued on January 16.
The UDI Rule requires a device to have a UDI on its label and packages unless an exception or alternative applies. 21 C.F.R. § 801.20. There are special labeling requirements that apply to stand-alone software regulated as a device. 21 C.F.R. § 801.50). Additionally, the rule requires that certain dates on device labels be in a standard format. FDA’s UDI system is designed to capture information regarding distributed and used devices and to incorporate this information in an integrated health system, including in the supply chain, registries, and electronic health records.
The UDI requirements have been phased in over the last five years beginning with highest-risk, Class III devices. The final two phases are set to occur on September 24, 2018 and September 24, 2020 with implementation of the below requirements:
|September 24, 2018||A class II device that is required to be labeled with a UDI must be permanently marked with a UDI on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.|
|The labels and packages of class I and unclassified devices (i.e., those that have not been classified into class I, class II, or class III) must bear a UDI. § 801.20.|
|Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.|
|Data for class I and unclassified devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.|
|Class I stand-alone software must provide its UDI as required by § 801.50(b).|
|September 24, 2020||Class I and unclassified devices that are required to be labeled with a UDI, must be permanently marked on the device itself with a UDI if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.|
Since June 2014, 5% of guidances (8/152) issued by CDRH related to UDI topics. This number of guidances is remarkable given the time it takes to draft and review guidance documents, and the multitude of other important topics CDRH must address. Among these guidances was the November 2017 guidance relating to direct marking of devices with a UDI. This guidance is noteworthy for those entities required to comply with the Class II marketing requirements taking affect in September 2018.
With the exception of the Class II direct marking requirements, last summer’s letter from FDA to industry extended all of the other upcoming compliance dates by two years. In this letter, FDA promised to issue guidance on articulating its enforcement discretion for the Class I and unclassified device compliance dates. On January 16, FDA issued such guidance: the immediately-in-effect (for new acronym connoisseurs, IIE) document entitled, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The below table shows the original and new compliance dates based on the guidance.
|Original Compliance Date||Requirement||New Compliance Date|
|September 24, 2018||Class II device direct marked with UDI||September 24, 2018
|Labels and packages of class I and unclassified devices include UDI||September 24, 2020|
|Dates on the labels of all devices to be formatted as required by § 801.18.||September 24, 2020|
|Data for class I and unclassified devices submitted to GUDID||September 24, 2020|
|Class I stand-alone software to provide its UDI||September 24, 2020|
|September 24, 2020||Reusable and reprocessed class I and unclassified devices direct marked with a UDI||September 24, 2022|
According to the guidance, this extension was granted so that the Agency and industry could identify and address policy and technical challenges to ensure that UDI data are high quality, available, and integrated in standardized and meaningful ways from higher risk devices before focusing on lower risk devices.
In the guidance, FDA distinguishes between class I and unclassified devices manufactured and labeled on or after the original compliance date (September 24, 2018) and finished devices manufactured and labeled prior to the original compliance date established by the FDA. The latter group is excepted from the requirement to bear a UDI for a period of three years after that compliance date. In other words, if your device is manufactured before September 24, 2018, this inventory is afforded a three year exemption out to September 24, 2021. Practically speaking, this means that pre-September 24, 2018 inventory does not need to be reworked to include a UDI on its label or package until September 24, 2021. If your device is manufactured between September 24, 2018 and September 24, 2020, you lose this rework grace period and are expected to comply with UDI requirements as of the new compliance date (September 24, 2020). This might prove to be complicated logistically; companies will need to rework inventory built between September 24, 2018 and September 24, 2020 before the new compliance date while not needing to rework pre-September 24, 2018. FDA offers no rationale for the use of different, misaligned compliance dates.
While this guidance is intended to reduce the burden associated with the UDI rule for finished devices, it appears that misalignment between enforcement dates for devices manufactured before September 24, 2018 and between September 24, 2018 and September 24, 2020 could actually create more burden and confusion. We recommend interested parties comment on the burden that this misalignment will create in two and a half years when the requirements will take effect.
* Senior Medical Device Regulation Expert