United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-01-22 article Proposed Rules D09002ee1c7f6a3c8 D09002ee1c7f6a444 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT). 81 FR 3751 https://www.govinfo.gov/app/details/FR-2016-01-22/2016-01173 2016-01173 fr22ja16-18 4164-01-P Docket No. FDA-2014-N-1209 https://www.govinfo.gov/app/details/FR-2016-01-22/2016-01173 https://www.govinfo.gov/content/pkg/FR-2016-01-22/html/2016-01173.htm https://www.govinfo.gov/content/pkg/FR-2016-01-22/pdf/2016-01173.pdf Medical Devices Neurological Devices 12 p. 3751 3762 81 FR 3751 Title 21 Part 882 21 CFR Part 882 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression; Federal Register Vol. 81, Issue PRORULE 2016-01173 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-04-21 Docket No. FDA-2014-N-1209 4164-01-P 2016-01173 Proposed order.

The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT).

Submit either electronic or written comments on this proposed order by April 21, 2016. See sections IX and XVII of this document for, respectively, the proposed dates when the new requirements apply and the proposed effective date of a final order based on this proposed order. Michael Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-6283, michael.ryan@fda.hhs.gov. Medical Devices Neurological Devices Neurological Devices: Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression , michael.ryan@fda.hhs.gov http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM330887.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM335752.pdf http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 14 Office of the Federal Register, National Archives and Records Administration 2016-01-22 continuing daily deposited born digital 249 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-01-22 P0b002ee18e5a9888 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22ja16 https://www.govinfo.gov/app/details/FR-2016-01-22 https://www.govinfo.gov/content/pkg/FR-2016-01-22/pdf/FR-2016-01-22.pdf https://www.govinfo.gov/content/pkg/FR-2016-01-22/xml/FR-2016-01-22.xml fdlp 3699 3937 DGPO 2016-01-22 2024-06-02 FR-2016-01-22 machine generated eng FR FR-2016-01-22 81 14