FDA Finalizes Guidance on Neurological Device Trials
Posted 04 November 2016 | By
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.
FDA finalized the guidance in quick fashion after releasing the draft version for comment in March 2016, making few changes to the document.
The guidance has drawn praise from the Alzheimer's Association as well as two associations representing neurological surgeons.
"With specific information study design and submission, this guidance may expedite safe, effective devices to market, improving patients' quality of life," wrote Robert Egge, executive vice president of government affairs at the Alzheimer's Association.
However, FDA chose not to incorporate the comments it received from the Physicians Committee for Responsible Medicine, which called on the agency to further emphasize the need for "human-focused" data to support such device studies.
"In order to more quickly and efficiently develop neurological medical devices that slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes, basic and preclinical research should incorporate human-based studies and tests as early and often as possible. Human-focused tests are more likely to provide information that is relevant to humans, and thus, meaningful to patient outcomes in the clinic and beyond," the group wrote.