| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
062
|
Date of Entry 05/29/2024
|
|
FR Recognition Number
|
17-18
|
| Standard | |
IEEE Std 2010-2023
Recommended Practice for Electroencephalography (EEG) 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
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
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| FDA recognition of IEEE Std 2010-2012 [Rec# 17-13] will be superseded by recognition of IEEE Std 2010-2023 [Rec# 17-18].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*
1. AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.
2. 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.
3. Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff, issued July 2011.
4. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
5. Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued June 2022.
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 Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
