FDA Releases IDE Guidance on Neurological Device Trials
The US FDA has issued final 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 medical devices designed to target the cause or progression of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia. The final guidance offers general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.
Investigational Plans
An IDE application should include the complete, or at least a summary, of the investigational plan, which also must contain a description of the device and its important components.
For each planned clinical study, the following should be provided:
- the proposed indications for use, which should include the target population;
- the study type (e.g., pivotal, expansion or feasibility trial);
- the design of the study, including objectives, any masking, randomization, and controls (e.g., best medical management, delayed time-to-treatment in the control arm in comparison to active treatment);
- the total time planned for subject follow-up;
- the number of subjects you plan to enroll (sample size);
- the number of investigational sites, both inside and outside the U.S.;
- the subject inclusion and exclusion criteria;
- primary safety and effectiveness endpoints described as specific objective clinical targets;
- a study plan detailing tests and testing methodologies one plan to test in the subjects;
- a schedule/time table of all clinical tests to be performed for pre- and post-¬ operative evaluation of the subjects.
- the participating investigators, if known.
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