Archive for: Guidance

  • ORIGINAL ANALYSIS

  • PDF DOWNLOAD

  • EXTERNAL LINK

  • POST

Diagnostics: Guidance

CMS Holds Informational Call on PAMA Data Collection

CMS hosts informational Open Door Forum to discuss the 2019 PAMA Data Collection process and related requirements.

POST

Diagnostics: Guidance

CMS Publishes CLIA User Fee Update

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

EXTERNAL LINK

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FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

POST

Load more
beakernav X1E2BFA62-BFCE-43C1-B777-27E3E5216018medical bagoriginal analysis +external linkpdf downloadstethoscope