Archive for: Laboratory

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Diagnostics: Guidance

FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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Diagnostics: OIG

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data

OIG releases the fourth in a series of data briefs looking at Medicare spending under the Clinical Laboratory Fee Schedule.

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