The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices as experimental or nonexperimental based on initial questions of efficacy and safety. The CMS uses these categorizations when making decisions regarding Medicare reimbursement.

The FDA published draft guidance to adjust its policy on categorizing investigational device exemption (IDE) devices to help the Centers for Medicare & Medicaid Services (CMS) make reimbursement decisions. In late 2015, the FDA’s Center for Devices and Radiological Health (CDRH) and the CMS’ Coverage and Analysis Group (CAG) signed a memorandum of understanding (MOU) to establish a more efficient process to categorize investigational medical devices in order to support the CMS’ ability to make Medicare reimbursement decisions. The draft guidance is designed to implement the MOU, which came into effect June 2, 2016, by outlining the framework the FDA will follow for such decisions.

The MOU and draft guidance follow the CMS’ modification in 2013 of the definitions for Category A and Category B devices. The categories, outlined in the Code of Federal Regulations (CFR) at 42 CFR 405.201, include:

  • Category A or experimental: Devices for which the absolute risk has not been determined and for which it’s unclear whether the device is safe and effective.
  • Category B or nonexperimental/investigational: Devices for which incremental risk is the primary risk in question, meaning the device is known to be safe and effective.

The draft policy outlines the criteria the FDA will use to categorize devices when an IDE is approved or approved with conditions. A device will be considered Category A if it meets one of the following criteria:

  • No premarket (PMA) approval, 510(k) clearance or de novo request has been granted, and initial safety and efficacy questions have not been resolved in nonclinical or clinical studies.
  • The device has characteristics that differ from those of a legally marketed device, and the existing information on the marketed device does not resolve initial efficacy and safety questions.
  • The device is being investigated for a new indication or new intended use for which information from a similar device related to the previous indication does not resolve initial efficacy and safety questions.

A device will be considered Category B if it meets one or more of the following criteria:

  • No PMA approval, 510(k) clearance or de novo request has been granted, but existing data resolves initial safety and efficacy questions.
  • The device has characteristics similar to a legally marketed device, and available information resolves initial safety and efficacy questions.
  • The device is being studied for a new indication or use, but information from a previous indication resolves initial safety and efficacy questions.

The draft policy also indicates that a change in categorization may be warranted if evaluations provide sufficient data to resolve initial questions of safety and efficacy or if an IDE study receives a staged approval or staged approval with conditions. In such circumstances, the FDA will make a categorization decision upon study approval, study expansion or submission of a request to change the category.