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Objective: Despite advances in the treatment of psychiatric diseases, currently available therapies do not provide sufficient and durable relief for as many as 30-40% of patients. Neuromodulation, including deep brain stimulation (DBS), has emerged as a potential therapy for persistent disabling disease, however it has not yet gained widespread adoption. In 2016, the American Society for Stereotactic and Functional Neurosurgery (ASSFN) convened a meeting with leaders in the field to discuss a roadmap for the path forward. A follow-up meeting in 2022 aimed to review the current state of the field and to identify critical barriers and milestones for progress., Design: The ASSFN convened a meeting on June 3, 2022 in Atlanta, Georgia and included leaders from the fields of neurology, neurosurgery, and psychiatry along with colleagues from industry, government, ethics, and law. The goal was to review the current state of the field, assess for advances or setbacks in the interim six years, and suggest a future path forward. The participants focused on five areas of interest: interdisciplinary engagement, regulatory pathways and trial design, disease biomarkers, ethics of psychiatric surgery, and resource allocation/prioritization. The proceedings are summarized here., Conclusion: The field of surgical psychiatry has made significant progress since our last expert meeting. Although weakness and threats to the development of novel surgical therapies exist, the identified strengths and opportunities promise to move the field through methodically rigorous and biologically-based approaches. The experts agree that ethics, law, patient engagement, and multidisciplinary teams will be critical to any potential growth in this area., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Sarah Bick receives funding from the Neurosurgery Research and Career Development Program (K12 NS080223) and consulting honoraria from Varian Medical Systems. Rafael Carbunaru owns stock options and is an employee of Boston Scientific, a manufacturer of DBS devices. Jennifer Chandler receives funding from CIHR (Canadian Institutes of Health Research) through the ERANET-Neuron program. Binith Cheeran owns stock options and is an employee of Abbott, a manufacturer of DBS devices. Rachel Davis receives consulting honoraria from Medtronic and speaker fees from Baylor for an OCD conference. Darin Dougherty's research has been funded by the International OCD Foundation, Brain and Behavior Research Foundation, National Institute of Mental Health, Tiny Blue Dot Foundation and Medtronic; he has received honoraria and consultation fees from Medtronic, Sage, and Celanese and has equity in Neurable, Innercosmos, and Intrinsic Powers. Ashley Feinsinger receives funding from the NIH (RF1MH121373 and UH3NS103442), received honoraria for her work on the NIH Neuroethics Workgroup, she is on an advisory board of Vivani Medical Products (Orion Early Feasibility Study), and she is on the data safety monitoring board of R01 MH122431. Kelly Foote reported grants from the National Institutes of Health during the conduct of the study; nonfinancial support from Medtronic (donation of closed-loop DBS devices) outside the submitted work; and grants from Medtronic, Boston Scientific, and Functional Neuromodulation outside the submitted work. Wayne Goodman receives funding from NIH (UH3NS100459), the McNair Foundation, and Biohaven. WG receives royalties from Nview, LLC and OCDscales, LLC as well as consulting honoraria from Biohaven. Aysegul Gunduz receives investigational device donations from Medtronic under the NIH BRAIN Public-Private Partnership agreements, and her research is funded by NIH grants UH3NS095553, R01NS096008, UH3NS119844. Casey Halpern has patents related to sensing and brain stimulation for the treatment of neuropsychiatric disorders, and he works as a consultant for Boston Scientific Neuromodulation and Insightec. Brian Kopell has received consulting honoraria from Abbott and Medtronic. Cynthia Kubu receives grant funding from the NIH (5RO1MH114853, 5RC1NS068086, 3RF1MH123407-01S1) and participates on the data safety monitoring boards for studies investigating the use of DBS for pain (UHS3 BRIAN/UH3 HEAL, 3UH3NS113661). She is the president of the Society for Clinical Neuropsychology. Sarah Lisanby receives funding from the NIMH (1ZIAMH002955) and has a role on the Scientific Advisory Boards of the Aalto University School of Science and the German Center for Brain Stimulation. Cameron McIntyre is a paid consultant for Boston Scientific Neuromodulation, receives royalties from Hologram Consultants, Neuros Medical, Qr8 Health, and is a shareholder in the following companies: Hologram Consultants, Surgical Information Sciences, BrainDynamics, CereGate, Autonomic Technologies, Cardionomic, Enspire DBS. Michael Okun serves as Medical Advisor for the Parkinson's Foundation, and has received research grants from NIH, Parkinson's Foundation, the Michael J. Fox Foundation, the Parkinson Alliance, Smallwood Foundation, the Bachmann-Strauss Foundation, the Tourette Syndrome Association, and the UF Foundation. Michael Okun's research is supported by: NIHR01 NR014852, R01NS096008, UH3NS119844, U01NS119562. Michael Okun is PI of the NIH R25NS108939 Training Grant. Michael Okun has received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, Perseus, Robert Rose, Oxford and Cambridge (movement disorders books). Nader Pouratian receives research funding from NIH (R24 MH114796, UH3 NS103442, UH3 NS103549, R01 NS097782, UH3 NS113661, R01 GM135420, RF1 MH121373), consulting/presentation honoraria from Abbott, Sensoria Therapeutics, Boston Scientific, and BrainLab. Nader Pouratian is on an advisory board at Abbott Laboratories and has leadership positions in the Congress of Neurological Surgeons and American Society of Stereotactic and Functional Neurosurgery. Robert Raike owns stock options and is an employee of Medtronic, a manufacturer of DBS devices. Patricio Riva-Posse has received honoraria for consulting for Janssen Pharmaceuticals, Abbott Neuromodulation, and LivaNova. Sameer Sheth received funding from the McNair Foundation for this work. SS receives consulting honoraria from Boston Scientific, Neuropace, Zimmer Biomet, and Koh Young. Nora Vanegas-Arroyave receives research funding from NIH and the Michael J. Fox foundation. Alik Widge has received honoraria for consulting for Abbott, he has received device donations from Medtronic, and he has unlicensed patents in the area of deep brain stimulation., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review-from device classification and clinical studies to the final marketing application-FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices. [ABSTRACT FROM AUTHOR]