Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
How to Prepare a Successful Human Factors Engineering and Usability Engineering (HFE/UE) Report
HFE/UE reports that only summarize HF usability validation evaluations won’t pass muster with FDA reviewers...
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Posted on Aug 26, 2014
Incorporating Dosage Strength into Packaging Design & Labeling Requirements
Last year, the Center for Drug Evaluation and Research (CDER) released the draft guidance Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. It was written with the intent to provide guidance on using packaging design and labeling to determine medical dosage strength. The guidance acknowledges that the use of colored labels can be effective in drawing the user’s attention to important information, but emphasizes that the color is more of a supplement to—rather than a replacement for—the information gained by actually reading the label. For this reason, CDER cautions that all labels must be properly evaluated to minimize the occurrence of medication errors.
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Posted on Aug 19, 2014