CPC Comments on Unique Device Identification System; Proposed Rule

The CPC’s comments on the Agency’s Unique Device Identification System proposed rule recommended that:
• The UDI system should not apply to cross-labeled combination products.
• UDIs should not be required for combination products unless there are no UDI or NDC numbers associated with product constituents.
• The exceptions to the UDI requirement (at 21 C.F.R. 801.30(11)) should be clarified.
• FDA clarify whether exceptions to the UDI requirements (at 21 C.F.R. 801.30) apply if a device is a stand-alone product or a constituent of a combination product.
• An exception to UDI requirements be added for device constituents being shipped for further processing as part of a combination product.
• FDA publish guidance on the application of UDI regulations.
• FDA harmonize regulations regarding combination products.