The FDA has issued a new draft guidance intended to assist FDA staff and those in the healthcare industry with submitting investigational device exemption (IDE) applications to conduct clinical trials for neurological medical devices.
The guidance applies to devices targeting the causes or progression of disorders such as Alzheimer's, Parkinson’s, and Primary Dystonia.
“Medical devices intended to slow, stop, or reverse the effects of neurological disease (neurological devices) face challenges with regard to collecting safety and efficacy data in a clinical study, when less invasive pharmacotherapy approaches may be better understood or more-well accepted in the clinical community,” the FDA said in the document’s introduction. “The Center for Devices and Radiological Health is issuing this draft guidance for Industry and FDA staff to assist in considering the benefits and risks of medical devices that target either the cause or progression of the neurological disorder or condition such as Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia, rather than their symptoms, and importantly, address an unmet medical need of the patient. 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.”
The draft guidance emphasized that all IDE applications must include complete investigational plans or, when appropriate, a summary of the investigational plan. The device’s proposed indications for use, the study type, and the total time planned for follow-up are just some of the things that make up a full investigational plan.
The guidance also focused on the importance of examining patient safety when submitting IDE applications.
“A risk analysis should also be part of any study, including steps to mitigate risks as well as identify the most likely types of adverse events and acceptable levels for the most probable and the most serious adverse events,” the FDA said in the document. “In some cases, products may have prior safety data or a well-defined safety profile due to its use for an alternate indication.”
The FDA is accepting comments until June 6.