These and other comments convinced
* Section 801.30(a)(11) provides that if a device is packaged within the immediate container of a combination product or convenience kit, the label of that device will not be required to bear a UDI, provided that the label of the combination product or convenience kit bears a UDI.
* Section 801.30(b) addresses situations where a combination product properly bears an NDC number. The NDC database is a system that, while different from the GUDID, permits tracking and identification. Crafting this exception for products with an NDC number avoids potentially redundant requirements. Section 801.30(b)(1) makes clear that a combination product that properly bears an NDC number on its label is not required to bear a UDI. As provided in
We believe this simplified approach is far more likely to be understood and correctly applied and minimizes the changes labelers need to make to current practices to be in compliance with the rule.
M. Medical Procedure Kits and Trays
We received comments that were concerned with how UDI requirements would apply to medical procedure kits and trays. A medical procedure kit typically consists of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to facilitate a single surgical or medical procedure. The medical procedure kit is typically packaged upon or within a medical procedure tray and is packaged so as to maintain sterility or to facilitate sterilization. The devices within a medical procedure kit are not necessarily individually packaged, so as to be ready to use immediately upon opening the medical procedure kit. A medical procedure tray is a tray or other container upon or within which the components of a medical procedure kit are arranged to facilitate a surgical or medical procedure. Orthopedic procedure kits are a well-known example of a medical procedure kit. These comments were primarily concerned that the rule would require changes in the way medical procedure kits are assembled and packaged, which could interfere with sterilization processes and the use of the medical procedure kit.
A medical procedure kit is either a convenience kit, if it contains only medical devices, or a combination product, if it contains both a device and a drug or biologic. The final rule excepts a device packaged within the immediate container of any convenience kit or within the immediate container of a combination product from bearing a UDI on its label provided, as long as the kit or combination product is labeled with a UDI in accordance with
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