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FDA Issues Final Guidance on IDEs

NEW YORK (360Dx) – The US Food and Drug Administration today issued a final guidance modifying its policy for categorizing investigational device exemption (IDE) devices used in clinical studies.

The policy is used by the Centers for Medicare & Medicaid Services to determine whether an IDE should be reimbursed by CMS. Last Friday, the FDA's Center for Devices and Radiological Health and CMS' Coverage and Analysis Group executed a memorandum of understanding "to streamline and facilitate the efficient categorization of investigational medical devices" to support CMS' ability to make those coverage decisions, the FDA added in its final guidance.

The final guidance is an update to an interagency agreement (IA) forged by the FDA and CMS in 1995 to cover reimbursements for investigational devices. Approved IDEs are categorized either as Category A or Category B devices by the FDA. Category A devices are deemed as being experimental and defined as "a device for which 'absolute risk' of the device type has not been established … and the FDA is unsure whether the device type can be safe and effective."

Category B devices are considered nonexperimental/investigational and are defined as devices "for which the incremental risk is the primary risk in question … or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type."

In modifying its policy, the FDA noted that since the original IA, it has received "a number" of IDEs that does not fit "easily" into any of the eight subcategories originally identified. For example, the first policy "did not adequately" describe categorization criteria relevant for certain early feasibility studies, which are studies very small in size that allow for the early clinical evaluation of devices, of which there may not be a final design. 

The FDA noted that proper categorization criteria was missing, "particularly those for devices similar to approved devices but with modifications which raise significant new safety question. As a result of this, and the recent increases in [early feasibility study] submissions subsequent to the publication of [an earlier] guidance document … FDA has determined that additional clarification of FDA's approach to these categorization criteria is warranted."

Additionally, the agency noted that there may be situations when it may be appropriate to switch a device from Category A to Category B, or vice versa, and the original IA does not provide a pathway for such changes.

The FDA will discuss the final guidance in a webinar schedule for Jan. 18, 2018.