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Guidance On Lab-Developed Tests, Adverse Event Reporting Among US FDA's Priorities For FY 2016

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration's device center has released its annual guidance priority list1, saying it "fully intends" to release final guidance documents on the Medical Device Reporting regulation, Unique Device Identification direct marking, regulatory oversight of laboratory-developed tests and use of ISO 10993-1 biocompatibility standards, among others1.




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