Literature DB >> 27930909

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.

Leigh Anderson1, Patrick Antkowiak1, Aden Asefa1, Amber Ballard1, Tushar Bansal1, Ayo Bello1, Bernard Berne1, Kristen Bowsher1, Bennett Blumenkopf1, Ian Broverman1, Mohamad Bydon1, Kuo Chao1, Peter Como1, Karlene Cork1, Ann Costello1, Kathryn De Laurentis1, Angela DeMarco1, Heather Dean1, John Doucet1, Bradley Dworak1, Lisa Epperson1, Eric Franca1, Naz Ghassemian1, Chandramallika Ghosh1, Anupama Govindarajan1, Jay Gupta1, Stacie Gutowski1, Robert Herrmann1, Michael Hoffmann1, William Heetderks1, Steven Hsu1, Daryl Kaufman1, Erin Keegan1, Gregg Kittlesen1, Kevin Khuu1, Hyung Lee1, Larry Lo1, Ian Marcus1, Timothy Marjenin1, Binoy Mathews1, Sanjay Misra1, Vivek Pinto1, Vesper Ramos1, Samuel Raben1, Avena Russell1, Devjani Saha1, Joonil Seog1, Christian Shenouda1, Myra Smith1, Xiaorui Tang1, Kelliann Wachrathit1, Jaime Waterhouse1, Dhanya Williams1, Xiaolin Zheng1, Carlos Peña2.   

Abstract

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients. Published by Elsevier Inc.

Entities:  

Mesh:

Year:  2016        PMID: 27930909     DOI: 10.1016/j.neuron.2016.10.036

Source DB:  PubMed          Journal:  Neuron        ISSN: 0896-6273            Impact factor:   17.173


  4 in total

1.  Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders.

Authors:  Ausaf A Bari; Charles B Mikell; Aviva Abosch; Sharona Ben-Haim; Robert J Buchanan; Allen W Burton; Stephen Carcieri; G Rees Cosgrove; Pierre-Francois D'Haese; Zafiris Jeffrey Daskalakis; Emad N Eskandar; Jason L Gerrard; Wayne K Goodman; Benjamin David Greenberg; Robert E Gross; Clement Hamani; Zelma H T Kiss; Peter Konrad; Brian H Kopell; Lothar Krinke; Jean-Philippe Langevin; Andres M Lozano; Donald Malone; Helen S Mayberg; Jonathan P Miller; Parag G Patil; DeLea Peichel; Erika A Petersen; Ali R Rezai; R Mark Richardson; Patricio Riva-Posse; Tejas Sankar; Jason M Schwalb; Helen Blair Simpson; Konstantin Slavin; Paul H Stypulkowski; Tor Tosteson; Peter Warnke; Jon T Willie; Kareem A Zaghloul; Joseph S Neimat; Nader Pouratian; Sameer A Sheth
Journal:  J Neurol Neurosurg Psychiatry       Date:  2018-01-25       Impact factor: 10.154

Review 2.  Current and Emerging Clinical Treatment in Mitochondrial Disease.

Authors:  Rory J Tinker; Albert Z Lim; Renae J Stefanetti; Robert McFarland
Journal:  Mol Diagn Ther       Date:  2021-03-01       Impact factor: 4.074

Review 3.  Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke.

Authors:  Christopher M Loftus; Michael Hoffmann; William Heetderks; Xiaolin Zheng; Carlos Peña
Journal:  Front Neurol       Date:  2018-06-11       Impact factor: 4.003

4.  Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review.

Authors:  Saskia Hendriks; Christine Grady; Khara M Ramos; Winston Chiong; Joseph J Fins; Paul Ford; Sara Goering; Henry T Greely; Katrina Hutchison; Michael L Kelly; Scott Y H Kim; Eran Klein; Sarah H Lisanby; Helen Mayberg; Hannah Maslen; Franklin G Miller; Karen Rommelfanger; Sameer A Sheth; Anna Wexler
Journal:  JAMA Neurol       Date:  2019-10-17       Impact factor: 29.907

  4 in total

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