| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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4-185
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| Standard | |
ANSI ASA S3.45-2009 (Reaffirmed 2019)
American National Standard Procedures for Testing Basic Vestibular Function |
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Scope/AbstractThis 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.
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| Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §882.1460 |
Nystagmograph
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Class 2
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GWN
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| §890.1575 |
Platform, Force-Measuring
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Class 1
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KHX
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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. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
