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CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center issued its annual “A List” and “B List” guidance priorities for fiscal year 2016, spotlighting efforts to address Unique Device Identification direct marking, Medical Device Reporting rules, laboratory-developed tests, 510(k) third-party review, companion diagnostics, and more.

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