News & Analysis as of

Medicare Investigational Device Exemptions

Morgan Lewis

FDA Uses Summer to Issue Numerous Device Guidance Documents

Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

King & Spalding

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

King & Spalding on

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

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