Tag Archives: Packaging Control

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

Labeling and Packaging Control

By Dr. Christopher Joseph Devine
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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