An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
8. LABELING AND PACKAGING
Subpart K of the new regulation addresses labeling and packaging requirements to be fulfilled by device manufacturers. They combine the general and critical device labeling requirements of the 1978 GMP regulation. Although the new labeling requirements are not as detailed as those of the earlier regulation, all of the details included in the 1978 regulation still apply. The packaging requirements of both regulations are the same.
