FDA Announces Unchanged Final Guidance for IDEs for Neurological Diseases
The FDA has issued virtually unchanged final guidance to assist sponsors who intend to submit an IDE to conduct clinical trials on medical devices targeting neurological disease progression.
The guidance aims to help weigh the risks of medical devices that target either the cause or progression — rather than the symptoms — of neurological conditions such as Alzheimer’s disease and Parkinson’s disease.
For each planned clinical study, sponsors should include proposed indications for use and target population; study type (i.e., pivotal, feasibility); study design; total time planned; sample size; number of investigational sites; safety and effectiveness endpoints; details on tests and testing methodologies; and participating investigators. — Jeff Kinney