This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices. As we approach the Class II compliance date on September 24, 2016, it is important for industry members to understand the categories of devices which have been granted an extension and those that have not.
The FDA’s Class II extension applies only to the following three types of devices:
- Collections of multiple Class II devices or Class II devices packaged with Class I devices in which each device in the package is not individually labeled with UDI. The UDI Final Rule excepted individual devices packaged within a convenience kit from UDI labeling requirements. The FDA issued a draft guidance on convenience kits at the beginning of the year which clarifies the definition as follows: “For the purposes of UDI compliance, we interpret the term ‘convenience kit’ at 21 CFR 801.3 solely to apply to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.” Pending further clarification from FDA, it appears a product must meet the above definition in order to claim the extension until 2018.
FDA is currently reviewing comments from industry members on the draft guidance and is expected to issue a final guidance document at the conclusion of this process. This extension has been issued in part to provide FDA with sufficient time to address industry concerns and questions regarding the draft guidance.
- Repackaged Single-Use Devices (SUDs). This category applies only to repackaged devices created from Class II single-use devices not individually labeled with UDI. Pending further clarification from FDA, the manufacturer’s finished device supplied to the repackager must meet the SUD exception in the UDI Final Rule.
- Some Device Constituents in Combination Products. This category includes “co-packaged” and “cross-labeled” device constituents that are part of a combination product assigned to CDER or CBER for premarket review and regulation. Please note that, pending additional information from FDA, the device portion of these combination products will still require compliance with all UDI regulations by September 24, 2018.
Industry members should also be aware that the compliance date for all Implantable, Life-Supporting and Life Sustaining (I/LS/LS) devices passed in 2015. The FDA’s recent extension does not apply to Class II I/LS/LS devices, which should already comply with all applicable UDI requirements.
In a joint USDM/Reed Tech webinar yesterday, UDI expert Jay Crowley reminded the audience that this extension was granted at the FDA’s discretion for purposes of reviewing compliance requirements and could be withdrawn or amended at any time so, in Crowley’s words, “don’t get too comfortable with it.”
You may notice that many conditions apply to this extension and the definitions above are quite narrow. Industry members should review these requirements carefully and direct clarifying questions to the FDA UDI Help Desk, not making any assumptions about whether this extension applies to any of their products.
If, like the great majority of Class II labelers, you still face a 2016 UDI compliance date, you’re running out of time, with only eleven business days remaining before the deadline! Contact Reed Tech today for help.