As our readers know, the unique device identification system regulations require that the label and device package of a device must bear a UDI, unless an exception or alternative applies. One such exception is for devices packaged within the immediate container of a convenience kit if the label of the convenience kit bears a UDI. 21 C.F.R. § 801.30(a)(11).Unchanged from the draft guidance is FDA’s definition of a convenience kit: A convenience kit is “two or more different medical devices packaged together for the convenience of the user” (21 CFR 801.3).

The guidance also allows for finished devices held in inventory prior to their applicable UDI compliance dates to forego direct marking requirements provided that the UDI information can be derived through other information. Under 21 CFR § 801.30(a)(1), finished devices which were manufactured and labeled prior to their applicable UDI compliance date relative to the device classification have a safe harbor for 3 years prior to being subject to the full scope of applicable UDI requirements. In the new guidance, FDA foregoes compliance with direct marking of any such devices still held in inventory which would otherwise be subject to the direct marking requirements under 21 CFR 801.45 provided that the UDI information can be derived from other information marked on the device.

[ii] Enforcement discretion will not apply to class I or unclassified implantable, life supporting or life-sustaining devices because labelers of these types of devices must already be in compliance with the UDI requirements.[iii] Class I CGMP-exempt devices are excepted from the UDI requirements per 21 CFR 801.30(a)(2). [View source.]

The draft guidance defines a convenience kit for purposes of the UDI rule as being “two or more different medical devices packaged together for the convenience of the user where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.” This definition is important because if a kit meets the definition of a convenience kit then only the kit label is required to include a UDI and the individual devices within the kit are exempt from the requirement to bear a UDI. 21 C.F.R. § 801.30(a)(11). If a kit does not meet the definition then each individual device in the kit will be required to comply with the applicable UDI requirements.