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of a convenience kit if the label of the convenience kit bears a UDI. 21 C.F.R. § 801.30(a)(11).Unchanged from the draft guidance is FDA’s definition of a convenience kit: A convenience kit is “two or more different medical devices packaged together for the convenience of the user” (21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). FDA interprets this to mean a device that contains two or more different medical devices packaged together and intended to remain packaged together and not to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user.

There are parts of the rule that do deserve further clarification, but those issues are not addressed.For example, the definition of an implantable device is one that “is intended to remain implanted continuously for a period of 30 days or more.” 21 C.F.R. § 801.3. By this definition, extended wear contact lenses are considered implantable devices, since they are intended to remain in the eye for 30 days. Nevertheless, we assume that FDA did not intend to include extended wear contact lenses in the definition of an implantable device.