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Device Labeling Deficiency Evaluation Conclusion
Device problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use). (Food and Drug Administration)
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Support contact information for a device labeler.
An individual that labels a device.
A device that is intended for one use, or on a single patient during a single procedure (Title 21 Chapter 9 Federal…
Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions).
Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or…
A problem with the mechanical, electrical, or communication interface between two or more separate devices or components.
