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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 038 FR Publication Date: 01/27/2015 

Part B: Supplementary Information

Recognition Number 17-13: IEEE Std 2010-2012, recommended practice for neurofeedback systems. (Neurology)

Date of Standard: 2012. 
Address of Standards Development Organization:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF NEUROLOGICAL AND PHYSICAL MEDICINE DEVICES (DNPMD)
(2)OFFICE OF COMPLIANCE (OC)
DIVISION OF ENFORCEMENT B (DOEB)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
DIVISION OF BIOMEDICAL PHYSICS (DBP)
(4)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
DIVISION OF POSTMARKET SURVEILLANCE (DPS)
POSTMARKET EVALUATION BRANCH II (PEBII)
Devices Affected:
Biofeedback devices that use electroencephalograph (EEG) (for any intended use or IFU) and cutaneous electrodes used with such systems.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard.
Related CFR Citations and Product Codes:
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 Guidance:
"Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance," April 1996

ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process

21 CFR 898 (Performance Standard for Electrode Lead Wires and Patient Cables)

"Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables," March 1998
http://www.fda.gov/ohrms/dockets/98fr/980448gd.pdf

"For Industry and FDA Staff Guidance1 on Electrosurgical Devices and the Application of the Performance Standard or Electrode Lead Wires and Patient Cables," November 1999

"Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Electrocardiograph Electrodes," July 2011
FDA Technical Contact:
 Michael Hoffmann
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1434
  Silver Spring MD 20993
  301/796-6476
  email: michael.hoffmann@fda.hhs.gov
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