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FDA Updates IDE Guidance Addressing Medicare Coverage

 
• By Elizabeth Orr

CMS may have an easier time determining when it should pay for an investigational device as FDA revamps its IDE device-classification scheme.

Medicare, Health Concept

A final guidance document is meant to clarify when products being studied under an investigational device exemption can be paid for by the Centers for Medicare and Medicaid Services (CMS).

The guidance modifies and updates US FDA’s policies on how to categorize devices used during clinical trials. It represents a major step in implementing a 2015 Memorandum of Understanding between FDA’s device center and the CMS coverage group, in which the two agreed that FDA would streamline device categorization to support CMS clinical-trial coverage decisions. FDA released a draft version of the document in May 2016

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