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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 17-13
Standard
IEEE  Std 2010-2012
Recommended Practice for Neurofeedback Systems
Scope/Abstract
This recommended practice describes electroencephalography (EEG) biofeedback (neurofeedback) systems and software to optimize the quality and availability of information available to device users.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of IEEE Std 2010-2012 [Rec# 17-13] will be superseded by recognition of IEEE Std 2010-2023 [Rec# 17-18]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 17-13] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 17-13] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.1320 Electrode, Cutaneous Class 2 GXY
§882.1400 Full-Montage Standard Electroencephalograph Class 2 GWQ
§882.1400 Reduced- Montage Standard Electroencephalograph Class 2 OMC
§882.5050 Device, Biofeedback Class 2 HCC
Relevant FDA Guidance and/or Supportive Publications*
AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.
For Industry and FDA Staff: Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables, Issued November 1999.
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Electrocardiograph Electrodes, Issued July 2011.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Heather Dean
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-9874
  Heather.Dean@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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