February 23, 2016 – Fisher Wallace Laboratories filed an amendment to its 2012 citizen petition at the FDA for regulatory activities related to cranial electrotherapy stimulator (“CES”) devices. The amendment requests that the Commissioner (1) investigate possible noncompliance with applicable Federal requirements, or misconduct, by not only he Center for Devices and Radiological Health (“CDRH”), but by personnel in the Commissioner’s office, in regard to the regulation of CES devices, (2) order CDRH to refrain from issuing a final rule to require the filing of a premarket approval application or a notice of completion of a product development protocol for CES devices indicated for use in the treatment of depression, and (3) immediately reclassify CES devices, thereby placing all legally marketed CES devices in class II.
The petition was filed originally on March 9, 2012 at the Food and Drug Administration. This amendment is captioned: Amendment No. 1-Citizen Petition, No. FDA-2012-P-0260-0001/CP.
By: Rachael Million-Perez