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OK...I am told that the answer to this is 'common sense', but honestly, I have learned not to rely on that as a basis for regulatory-type judgement calls.
In the spirit of going green and saving on printing and packaging costs, I have suggested using preloaded and content-protected flash drives to replace the printed package insert (~8 pages). The flash drive would also contain all of the translations of the insert, MSDS, COA, other related information. Since our assay requires raw data to be transferred from instrument to a separate PC, the flash drive would also serve as a mechanism to accomplish that.
The flash drive would be marked with the 'information icon' (book, small i) and the assay name. At most a card could be inserted to direct users to the information on the flash drive.
Is this idea compliant with IVD regs? I cannot find any requirement that the information be printed.
In the spirit of going green and saving on printing and packaging costs, I have suggested using preloaded and content-protected flash drives to replace the printed package insert (~8 pages). The flash drive would also contain all of the translations of the insert, MSDS, COA, other related information. Since our assay requires raw data to be transferred from instrument to a separate PC, the flash drive would also serve as a mechanism to accomplish that.
The flash drive would be marked with the 'information icon' (book, small i) and the assay name. At most a card could be inserted to direct users to the information on the flash drive.
Is this idea compliant with IVD regs? I cannot find any requirement that the information be printed.