FDA Spells Out Data to Support IDE Applications for Neurological Devices

March 11, 2016

The FDA is aiming to clarify the types of data it would like sponsors to submit to support an IDE for clinical trials involving devices targeting neurological disease progression.

In draft guidance dated March 7, the agency acknowledges that sponsors of devices that treat conditions such as Alzheimer’s disease face unique challenges, as many in the clinical community are more familiar with pharmaceutical options.

However, the agency sees potential for devices to control progression of these diseases and would like stakeholder input on the risks and benefits of using these devices.

“This draft guidance is intended to leverage advances in the state of science, and facilitate faster, more efficient device development, regulatory evaluation, and ultimately approval/clearance of innovative devices,” the document states.

To that end, the agency advises sponsors to include the complete investigational plan in their IDE applications. In addition, sponsors should describe all phases of the clinical investigation, detailing any anticipated study and explaining any plans to pool data from more than one phase.

Further, for each planned clinical study, sponsors should include the following:

  • 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;
  • The total time planned for subject follow-up;
  • The 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;
  • A schedule/time table of all clinical tests to be performed for pre- and post-operative evaluation of the subjects; and
  • The participating investigators, if known.

The agency also recommends using a benefit-risk framework to support “a comprehensive, balanced decision-making approach.” It adds that it may disapprove an IDE application if there is reason to believe that the risks outweigh the anticipated benefits to the subjects.

Comments are due by June 5. Read the draft guidance, Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes, here: www.fdanews.com/03-16-FDAIDE.pdf. — Jonathon Shacat