BY JAMES GIORDANO, PhD
Recently, the Food and Drug Administration (FDA) solicited input to guide ways that the agency regards and handles “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes”, in accordance with good practices regulation (21 CFR 10.115). The FDA will use this draft guidance to “…assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes”, and “… aid industry and FDA staff in considering the benefits and risks of medical devices that target … the cause or progression of neurological disorders or conditions” (such as movement disorders, like Parkinson’s disease and dystonia; as well as other pathologies, like Alzheimer’s dementia, Tourette’s syndrome, chronic pain, and psychiatric conditions such as depression).
The goal of the FDA regulation process is to establish that drugs and devices provided for medical care are safe and technically sound and the general constructs of Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) are aligned with such aims. But like any policies that tend to entail broad concepts, the real-world utility, viability and value of these programs are contingent upon: (1) the relative appropriateness to the context(s) in which any device is employed; and (2) if and how use-in practice reflects and is supported by the scope of regulatory oversight and control.
In recent years, IDE and HDE application, review and approval has become easier and more efficient; this is a notable improvement – and a step in the right direction.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.