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Martin Murray

FDA Proposes Packaging Changes

By January 3, 2013

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Packaging Challenges Packaging is going to be harder for manufacturers of medical devices with the FDA's proposal for unique device identification (UDI). The proposal for UDI is in two parts, firstly there needs to be a device identifier that identifies the specific version or model of a device and the manufacturer of that device. Secondly there should be an identifier that either shows the batch number of the device, serial number of the device, expiration date of the device, or the date a device was manufactured. The device identifier would be a reference number that allows a healthcare provider or the FDA to find data concerning the device.

If a device is sold in an individual package, that are sold as a box of ten, that are then in a carton of 10 boxes, the UDI would be need to appear on the individual device package and all the boxes and cartons. Manufacturers of medical devices are concerned that this proposal could significantly raise costs, due to significant changes in the packaging lines. Some companies estimate that the changes could cost every manufacturer tens of millions of dollars.

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