UDI Series: Quality Management System Compliance

Two new sections were added to FDA’s 21 CFR (Code of Federal Regulations) with the release of the Unique Device Identification (UDI) rule in September 2013. Subpart B, Labeling Requirements for Unique Device Identification, was added to 21 CFR 801; and 21 CFR Part 830, Unique Device Identification, was created.  Additionally, several sections of…
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Quality Plans as Proactive Tools for Successful FDA Inspections

QA Consulting often advises companies to generate quality plans to ensure that projects are implemented in an organized and comprehensive manner.  In addition to serving as objective planning tools, another inherent advantage of quality plans experienced by some companies has been the avoidance of 483 observations. Illustrated below are two companies QA Consulting recently worked…
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UDI Series: Successful Planning for UDI Implementation

In our first article on Unique Device Identification (UDI  we noted the UDI compliance deadlines set by the FDA that are staged over a span of six years, from September 24, 2014 to September 24, 2020. Each implementation date is dependent on several variables, including the device classification and whether or not the device is considered…
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