Developing Physician-Sponsored Investigational Device Exemption Protocols

Abstract

The practice of device modification is legal and unregulated by the United States government in most instances. However, the U.S. Food and Drug Administration (FDA) has wide and unlimited authority to intervene when patient safety or effectiveness of the device becomes a concern. The Center for Medicare and Medicaid Services (CMS), depending on the regional carrier, may choose to fully compensate or pay absolutely nothing for these cases based on an assessment of “investigational use.” Any practitioner who chooses to modify an existing FDA-approved medical device outside of an approved Investigational Device Exemption (IDE) clinical trial should weigh heavily the ramifications of a product liability claim and/or a criminal or civil liability claim, as the manufacturer becomes exempt once the device has been modified. It is the author’s opinion that physicians performing device modification of the nature described herein are obliged to obtain an IDE.