Last week, the FDA issued draft guidance modifying its current policy on categorizing Investigational Device Exemption (“IDE”) devices, in support of the Centers for Medicare & Medicaid Services’ (“CMS’s”) Medicare coverage decisions.  The guidance is intended to implement a Memorandum of Understanding (“MOU”) between the agencies to streamline and facilitate efficient categorization.  FDA requested that comments on the guidance be submitted by August 1, 2016 to be assured consideration before final guidance is issued.

The MOU on investigational devices replaces the 1995 interagency agreement between the FDA and CMS, and was prompted by the need to reflect definition changes and other changes made by CMS in its 2013 Medicare revised regulations on IDE coverage.  The CMS regulations went into effect January 2015 and, among other things, centralize the IDE coverage process, moving the responsibility for IDE device coverage decisions from the Medicare Administrative Contractors to CMS’s Coverage and Analysis Group.  The fundamental framework for coverage decisions, however, was not changed:  Once FDA has “approved” or “approved with conditions” an FDA study, the agency categorizes IDE devices as either Experimental (Category A) or Non-Experimental/Investigational (Category B).  CMS coverage for the IDE device depends on this categorization; CMS may only cover the Category B IDE device.  The routine care items and services furnished in an approved IDE study, however, may be covered for both Category A or B devices.

The draft FDA guidance underscores that the threshold distinction between Category A and B devices is that Category B devices have resolved initial questions about the safety and effectiveness of the device or similar device through available data (clinical or non-clinical).  This available data may include information on the IDE device itself or a legally-marketed similar device.  A device will generally be categorized as Category A if there is no such available data on initial questions of safety and effectiveness for one of the following situations: (1) there is no PMA approval, 510(k) clearance or granted de novo request for any indication, (2) the legally-marketed device has different characteristics, or (3) the device has undergone a significant modification for a new indication or intended use.  The draft guidance also offers examples of IDE devices that would fall into Category A and B, as well as a flowchart to illustrate the FDA’s decision tree for its decision-making.

The draft guidance also outlines considerations under which an IDE device’s categorization may be changed from A to B.  In short, the guidance provides that FDA will evaluate whether there is adequate data to change the device category upon study approval (for a new study), study expansion (for a staged study) or submission of a request to change categories.  This policy identifies new opportunities for coverage.  For example, in certain situations, early studies (such as early feasibility studies) may resolve questions of a Category A device’s safety and effectiveness, resulting in the same device receiving Category B designation in a subsequent study.  Building on this process, the draft guidance also identifies situations in which an IDE study receives a staged approval or staged approval with conditions.  FDA would permit expanded enrollment once an IDE supplement is found acceptable and, in some cases, the initial phase of the study can be used to resolve initial questions of safety and effectiveness.  This would mean a Category A device in the initial stage would be changed to Category B in the expanded study.  No such pathways were described in the 1995 interagency agreement.