FDA categorizes Investigational Device Exemption ("IDE") devices as either Category A (Experimental) or Category B (Nonexperimental/investigational) to assist CMS in making Medicare coverage decisions for devices provided in FDA-approved IDE studies. Medicare may pay for a Category B device if the study meets certain criteria, but Medicare will not pay for a Category A device. The framework for FDA's categorization was originally created in 1995 through an Interagency Agreement ("IA") with CMS (then HCFA) and IDE Guidance Memorandum #95-2 (which includes the IA as Attachment A).
Following CMS IDE regulatory updates in 2013 (C.F.R. ยง 405 Subpart B) and a 2015 Memorandum of Understanding between FDA and CMS (effective June 2, 2016, and replacing the 1995 IA), FDA recently announced the availability of a draft guidance document titled "FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff." The draft guidance modifies the criteria FDA will use when initially categorizing a device to be studied and then deciding whether to change a device's categorization, for example, based on new data. Once finalized, the guidance will supersede the Agency's 1995 guidance memorandum #95-2. FDA has requested comments on the draft guidance by August 1, 2016.
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