FDA Updates Investigational Device Guidance for CMS Coverage Decisions

December 7, 2017

The FDA is updating its policy on how medical devices with approved investigational device exemptions are categorized to help the Centers for Medicare and Medicaid Services make health insurance coverage decisions for Medicare beneficiaries.

The agency issued final guidance explaining the new framework CDRH and CBER will use when assigning IDE devices to one of two categories prior to clinical studies — Category A: Experimental and Category B: Nonexperimental/investigational.

The final guidance closely resembles the June 2016 draft version with some additional information on switching from Category B to A. It also includes new examples of data that can be used to support a category change.

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