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Background

On September 24, 2013, the United States Food and Drug Administration (FDA) published its final rule on Unique Device Identification (UDI). The final rule requires that most medical devices contain a UDI to help promote more accurate reporting and device identification. Under the final rule, a UDI must include:

1. a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and
2. a production identifier, which includes the current production information for a device (e.g., lot or batch, serial number, expiration, date of manufacture, etc.).

In addition, a labeler for a covered medical device is required to submit product information to FDA’s Global Unique Device Identification Database (GUDID). FDA has issued a companion Draft Guidance on GUDID submissions. The Draft Guidance provides an overview of how labelers will submit information to GUDID as required by the UDI final rule.

The proposed rule,¹ originally published on July 12, 2012, generated significant comments, with FDA receiving 1,700 pages of feedback. In response to these comments, the agency made more than 20 substantive changes in the final UDI rule. Below, we highlight some of these modifications.

Summary of UDI Final Rule Changes

Definitions

A new definition was added to define “Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device” for the purposes of clarifying when HCT/P products would be subject to the final rule. In addition, FDA modified its definition of “production identifier” (a term defined under the definition of unique device identifier) to include the distinct identification code for HCT/P products required by 21 C.F.R. § 1271.290(c).

The agency also modified the definition of “version or model” by removing reference to a “device package,” which was contained in the proposed rule.

Effective and Compliance Dates

FDA received numerous comments recommending changes to the compliance dates that were stated in the proposed rule. The agency acknowledged that the proposed rule mistakenly referred to compliance dates as “effective dates.” The final rule clarifies there are only two effective dates: the provisions of 21 C.F.R. §§ 801.55, 830.10, 830.100, 830.110, 830.120 and 830.130 are effective 30 days after federal register publication (October 24, 2013); all other provisions are effective 90 days after publication (December 23, 2013). FDA also clarified that the final rule is not applicable to devices put into commercial distribution prior to such devices’ applicable compliance date. The applicable compliance dates are dependent on the type of medical device (see summary of compliance dates).

Exceptions

The final rule added a new exception for “inventory devices” or finished devices that are manufactured and labeled prior to the relevant compliance date. An inventory device will not be subject to the UDI requirements for an additional three years from its applicable compliance date.
There is also a new process under the final rule whereby FDA, on its own or upon written request of a labeler, can grant a one-year extension of a compliance date. This process is limited to Class III devices or devices licensed under the Public Health Service Act and requires the agency to make a determination that the one-year extension is in the best interest of public health.

FDA eliminated a proposed exception for non-prescription devices sold at retail establishments. Under the final rule, however, Class I devices can use their Universal Product Code (UPC) as their UDI.

The proposed rule contained an exception for Class I single-use devices (SUDs). In response to comments, FDA expanded this exception to include all SUDs, except implants, regardless of device class.

FDA clarified that its proposed exception for Class I devices exempted from good manufacturing practice regulations includes Class I devices that had been exempted for most GMPs, but not for the recordkeeping rules under 21 C.F.R. §§ 820.180 and 820.198.

Under the proposed rule, UDI labeling would not have been required for certain device constituent parts of a combination product. In addition, the proposed rule had an exception for single-use devices in a convenience kit. The agency received several comments expressing concerns regarding the proposed exceptions for these types of devices. In response, FDA simplified this exception. Under the final rule, if a device is packaged within the immediate container of a combination product or convenience kit, that device is not required to have a UDI label, provided that there is a UDI label on the combination product or convenience kit. In addition, with respect to combination products, the final rule establishes that a product described under 21 C.F.R. § 3.2(e)(1) (“single-entity” combination product) is not subject to the UDI requirements if it properly bears a National Drug Code (NDC) number. A combination product described under 21 C.F.R. § 3.2(e)(2) (“co-packaged” combination products) must bear an NDC number and a UDI on its label.

Direct Marking of Devices

FDA received many comments in opposition to the proposed rule’s requirement on format of dates provided on medical device labels. Under the final rule, the date format will now be Year-Month-Day (e.g., 2014-10-19). The agency noted that the final rule date format is consistent with international standards. In addition, under the final rule, the date format requirement will have the same compliance date as the UDI labeling requirement.

The proposed rule would have required a specific symbol on a device label indicating the presence of automatic identification and data capture (AIDC) technology (if the AIDC was not visually apparent). FDA did not receive a single comment in support of this requirement. In response, the agency has eliminated the use of a specific symbol and the final rule only requires disclosure of AIDC technology.

FDA removed the direct marking requirement for implantable devices. Industry had expressed concern that direct marking could be too difficult because of the small size of many implantable devices. In addition, the final rule eliminates the requirement that labelers inform FDA if they believe their device is exempt from the direct marking requirements.

FDA expanded the direct marking requirement to include any devices that are “reprocessed” before each use. Previously, the proposed rule only included this requirement for reprocessed devices that were sterilized before each use.

Other Items

The final rule includes a new section covering stand-alone software that is regulated as a medical device. All such software is required to include means of displaying its UDI, regardless if it is in packaged form or not packaged (e.g., downloaded from the Internet).

FDA received comments about devices with NDC and National Health-Related Item Code (NHRIC) numbers previously assigned by the agency (“legacy numbers”). Under the proposed rule, the use of these numbers was to be discontinued in favor of UDIs. FDA has amended this provision in the final rule and will permit the usage of NDC and NHRIC numbers that have been previously assigned by the agency. Usage of such legacy numbers must be consistent with the UDI system operations of the issuing agency and the labeler must request and obtain FDA approval to use a legacy number.

The agency under the final rule modified the provisions that defined the types of changes that would result in a new version or model of a device (requiring a new UDI). The final rule is less prescriptive and gives labelers more flexibility (and responsibility) to determine when a change to their device would require a new UDI.

FDA added a requirement that the GUDID submissions include the Global Medical Device Nomenclature (GMDN) code for a device. Also, the agency is requiring that magnetic resonance imaging (MRI) compatibility information be submitted to the GUDID. Lastly, FDA added a new provision that explains the agency may inform a labeler if information submitted to GUDID appears to be incorrect. In such a case, the labeler would have 10 days to correct the information or otherwise provide FDA with an explanation.

Conclusion

The final rule is regarded as having many potential advantages for industry, including reduced risk of medical errors, more rapid identification of adverse event trends and inventory management. Medical device manufacturers should be aware of the applicable compliance dates for the type of devices (see summary of compliance dates) and whether they are covered under any of the final rule’s exceptions.