Devices

Policy Modifications for IDE Classification

David McFarland

— 1 min read
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FDA says a finalized guidance issued 12/5/17 modified the agency’s categorization of IDE devices used in clinical investigations. A 1/16 Webinar reviewed the guidance and the rationale for the changes.

FDAer Ken Skodacek, who works in the CDRH Clinical Trials Program and in the Payer Communication Task Force, said the guidance implements the memorandum of understanding between FDA and the Centers for Medicare and Medicaid Services (CMS) to facilitate the efficient categorization of investigational medical devices that ultimately supports the process that CMS uses to make Medicare coverage determinations.

FDA characterizes IDE devices based on whether available data demonstrates that initial questions of safety and effectiveness have been resolved, Skodacek said. Based on agency review of the information provided by the sponsor, IDE applications are placed in either Category A (experimental devices) or Category B (non-experimental investigation devices).

He listed three primary rationales for the new guidance: (1) previous agency policy on the categorization of IDEs did not adequately articulate criteria that are relevant to certain studies such as feasibility studies; (2) previous criteria did not consider all regulatory pathways, such as the de novo request; and (3) previous policy did not contain sufficient guidance on how a category designation may change.

Three elements that have changed in the guidance, he said, are: 

  •         the criteria have been simplified to ensure that the devices fall under the correct category;
  • ·         the final guidance provide an explanation of how a category change may occur; and
  •          the guidance has a number of examples that should help to clarify the revised criteria will be used by FDA staff.

Three elements that are not changed from a 1995 interagency agreement are: 

  •          an FDA review team makes the category designation;
  •          the category designation is to be based on the degree to which initial questions of safety and effectiveness are resolved; and
  •          the FDA categorization is used by CMS as part of its determination for whether items and services will be covered.

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