Device Labeling Evaluation Method

Reviewing all labeling (including instructions for use, manuals, and packaging) for language related to reported device problems. (Food and Drug Administration)

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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).

Device Labeler Support Contact

Support contact information for a device labeler.

Device Labeler

An individual that labels a device.

Device Labeled for Single Use

A device that is intended for one use, or on a single patient during a single procedure (Title 21 Chapter 9 Federal…

Device Known Inherent Risk of Procedure Evaluation Conclusion

Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions).

Device Ionizing Radiation Testing Evaluation Method

Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or…