FDA Issues Draft Guidance Request on Neurological Devices

The FDA has issued a draft guidance request for its document called Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.

According to the FDA, “the draft guidance is intended to assist Industry and FDA staff in considering the benefits and risks of medical devices that target either the cause or progression of a disorder such as Alzheimer’s, Parkinson’s or Primary Dystonia, rather than their symptoms.” Comments are being accepted through June 6, 2016.

You can find the draft guidance by going to www.regulations.gov and searching for docket number FDA-2016-D-0539.

File Attachments
  Draft Guidance (177K PDF)