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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Recognition 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
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§882.5050 Device, Biofeedback Class 2 HCC
§882.1400 Full-Montage Standard Electroencephalograph Class 2 GWQ
§882.1400 Reduced- Montage Standard Electroencephalograph Class 2 OMC
§882.1320 Electrode, Cutaneous Class 2 GXY
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.
FDA Technical Contact
 Heather Dean
  FDA/OMPT/CDRH/ODE/DNPMD/PMDB/
  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
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