Posted 04 December 2017
By Zachary Brennan
The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.
The guidance, first drafted in June 2016, describes the process and information FDA uses to determine the appropriate classification for a device to be studied.
"Importantly, the categorization paradigm has shifted from a more rigid approach to one which allows more flexibility and could be of great benefit specifically to manufacturers of, and patients receiving, innovative medical devices," FDA said, noting this categorization policy "has been revised in order to allow FDA to consider information known about investigational devices."
FDA notes that while a device may not be reimbursable during early clinical trials, "information gained during such studies now can be utilized to potentially help support a category change, and thus full reimbursement, for the device during subsequent studies."
The guidance discusses the reasons for the modification of this FDA policy, how the agency determines whether a sponsor has provided enough information to support initiation of a clinical study, and numerous examples.
The finalization of the guidance follows last week’s second-ever parallel review and approval of a next generation sequencing-based test.
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions