FDA Guidance on Patient Labeling

The FDA “Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers” dated 19-April-2001 is at the link provided. Although not specifically related to software we have posted this due to the close relationship between user manuals and software driven user interfaces. This guidance also has a section on usability testing related to the labeling.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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