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General Vs. Specific Use Final Guidance Emphasizes FDA Public Health Role

This article was originally published in The Gray Sheet

Executive Summary

FDA re-emphasizes its role as a guardian of public health by strengthening language in the final version of its "Guidance for Industry on General/Specific Intended Use," leaving the door open for reviewers to consider public health issues in deciding when a specific use of a device is covered by a general claim.

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