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.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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