Subject: Clinical Considerations for Investigational Device Exceptions (IDEs) for
Neurological Devices Targeting Disease Progression and Clinical Outcomes;
Draft Guidance Document for Industry and FDA Staff
Dear Dr. Pena:
On behalf of the American Association of Neurological Surgeons (AANS) and Congress of Neurological
Surgeons (CNS), we would like to thank you and your staff for developing the above referenced
Guidance Document for Investigational Device Exemptions (IDEs) for devices that target the cause or
progression of disorders such as Alzheimer’s, Parkinson’s or Primary Dystonia.
We agree with the agency that neurological devices such as neurostimulators designed to slow disease
progression and improve clinical outcomes represent a revolutionary option for patients, giving hope
where no successful treatment was previously available. These devices address a significant unmet
need for patients with devastating conditions. We commend FDA staff for issuing the proposed rule to
help manufacturers work with the agency as efficiently as possible to make safe and effective medical
devices available. We look forward to seeing the final guidance document.
Thank you for your time and attention. We appreciate the dedication and expertise of the FDA staff and
are eager to continue to work together on behalf of our patients.
…
Read full letter here
