Tag Archives: Packaging Control

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Labeling and Packaging Control

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Labeling and what constitutes being a label can be confusing for device manufacturers. This week, Devine Guidance explains 21 CFR, Part 820 – Subpart – K, Labeling and Packaging Control, specifically 820.120 (Device Labeling) and 820.130 (Device Packaging). There are three takeaways: The accuracy of device labeling is mission-critical for device manufacturers; product packaging and labeling need to be properly validated, including distribution cycles, storage conditions, and useable shelf life; and famil…

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