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# FDA Denies Vagus Nerve Stimulation Petition
- URL: https://www.fdaweb.com/fda-denies-vagus-nerve-stimulation-petition/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146872

FDA has denied a 9/6/06 Public Citizen Health Research Group petition asking it to revoke the Cyberonics PMA approval for its Vagus Nerve Stimulation device for managing treatment-resistant depression (TRD). The petition claimed that the device was “ineffective” for TRD and has not demonstrated a reasonable assurance that it is safe and effective for TRD.

The denial [letter](ttps://www.regulations.gov/contentStreamer?documentId=FDA-2006-P-0143-0007&attachmentNumber=1&contentType=pdf) says FDA determined in 2003 that the company had provided reasonable assurance of safety and effectiveness of the device for managing TRD. FDA says it disagrees with the petition’s contentions because **(1)** Public Citizen presented no evidence demonstrating that the VNS device is ineffective for managing TRD or any new evidence demonstrating a lack of a showing of reasonable assurance of safety and effectiveness for the device, and **(2)** the results of two post-approval studies required by the approval constitute additional valid scientific evidence supporting a reasonable assurance of safety and effectiveness of the device for managing TRD and the agency’s decision to approve it for that use.