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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 Entry 01/27/2015 
FR Recognition Number 4-185
Standard
ANSI ASA S3.45-2009 (Reaffirmed 2019)
American National Standard Procedures for Testing Basic Vestibular Function
Scope/Abstract
This Standard specifies procedures for conducting six separate tests, which, together with the data analysis and reporting requirements specified in this Standard, constitute the Basic Vestibular Function Test Battery. The six tests cover:

(a) spontaneous nystagmus (see 5.2);
(b) gaze-evoked nystagmus (see 5.3);
(c) saccade test (see 6);
(d) pursuit testing (see 7);
(e) positioning and positional nystagmus (see 8); and
(f) caloric testing (see 9).

Each of these tests evaluates a response of the vestibular system by the vestibulo-ocular reflex through the measurement of electrical signals generated by eye movements recorded by electrooculography.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.1460 Nystagmograph Class 2 GWN
§890.1575 Platform, Force-Measuring Class 1 KHX
Relevant FDA Guidance and/or Supportive Publications*
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
 Shu-Chen Peng
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6481
  shu-chen.peng@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASA Acoustical Society of America http://acousticalsociety.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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