Archive for: CLIA

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Diagnostics: Guidance

CMS Publishes CLIA User Fee Update

On December 28, 2018 CMS published its CLIA User Fee Update.

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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FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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