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FDA FACILITY REGISTRATION QUESTION:
Would our company be the repackager/relabler of the kits or the specification developer of convenience kits?
Our company manufacturers labels which are not medical devices. These labels are added to convenience kits and sold under our company name.
- Our company hires a kit assembler to assemble the convenience kits for medical procedures.
- Kit assembler adds our labels and a pen, with other items which are then sent to a sterilizing company.
- Kit assembler does not manufacturer any item in the kit.
- The kits are sold under our company's name.
What would be our registration activity - repackager/relabler OR specification developer ?
Would our company be the repackager/relabler of the kits or the specification developer of convenience kits?
Our company manufacturers labels which are not medical devices. These labels are added to convenience kits and sold under our company name.
- Our company hires a kit assembler to assemble the convenience kits for medical procedures.
- Kit assembler adds our labels and a pen, with other items which are then sent to a sterilizing company.
- Kit assembler does not manufacturer any item in the kit.
- The kits are sold under our company's name.
What would be our registration activity - repackager/relabler OR specification developer ?
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