The U.S. Federal Food, Drug , and Cosmetic Act regulates both labels and labeling of devices. While these terms are related to each other, they are not interchangeable.
The IFU (Instructions for Use) is a controlled document used by manufacturers to present the indicated uses, risks, and patient populations that the device is intended for. Medical devices can change frequently in relation to many of these claims, which then prompts a change to the IFU.
In keeping with our philosophy of LEAN manufacturing and eliminating waste in the manufacturing process, Phase 2 partners with our customers to provide on-demand printing of IFUs for the manufacturing floor. This prevents the expense of bulk purchase of printed materials, excess inventory, and the ability to respond quickly to changes.
IFU's and other printed materials that included in the packaging are printed on an as-needed basis to support the manufacturing floor. This includes the ability to include both static and variable information for labels. Some of the activities related to label and IFU printing are also part of our lot control and line-clearance process and we do not produce exactly the number of labels required for a lot build.