FDA Finalizes Guidance on Neurological Device Trials
Friday, November 4, 2016
The US Food and Drug Administration (FDA) on Friday finalized its guidance for sponsors looking to submit an investigational device exemption (IDE) to conduct clinical trials for neurological devices targeting disease progression in diseases such as Alzheimer's and Parkinson's.
"FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients," FDA writes.
However, FDA says that such devices can be difficult to study, as "less invasive pharmacotherapy approaches may be better understood or more-well accepted in the clinical community," despite their potential to address an unmet patient need.