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

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.

FDA's device center released its annual guidance priority list

, 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

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