Labeling requirements for individual units for medical devices



We will be packaging multiple devices into a single package (selling a box count of 100). All the appropriate label requirements will be on the box but I can't find information on requirements for the individual devices. They will be individually wrapped in film and the devices are large enough to contain information. We have devices that fall under the size exemption but not these. Does anyone know what labeling information is required on the individual units or does the information on the box suffice? Thank you!

Ronen E

Problem Solver
The FFDCA states:

The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(Emphasis added)

Hence, in my understanding the requirements applicable to "label" would apply to the film wrapper except if you can somehow categorise that wrapper as a liner. It might also be exempt if the wrapper is transparent and the label is implemented on the device itself.
Top Bottom