---
kind: "section"
citation: "21 C.F.R. § 886.1342"
title: "21"
number: "886.1342"
heading: "Strabismus detection device."
url: "https://uscodex.org/cfr/21/886.1342"
---

# §886.1342. Strabismus detection device.

- (a) **Identification.** A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination).
  - (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated:
    - (i) Verification of lowest detectable amount of deviation; and
    - (ii) **Validation of the accuracy and precision at the lowest detectable amount of deviation.**
  - (3) Software verification, validation, and hazard analysis must be performed.
  - (4) Optical radiation safety testing must demonstrate the device is safe per the directions for use.
  - (5) Performance testing must demonstrate the electromagnetic compatibility of the device.
  - (6) Performance testing must demonstrate the electrical safety of the device.
  - (7) Labeling must include the following:
    - (i) Summaries of non-clinical and clinical performance testing;
    - (ii) Instructions on how to correctly use and maintain the device;
    - (iii) Instructions and explanation of all user-interface components; and
    - (iv) **Information related to electromagnetic compatibility and optical radiation classification.**

## Notes

### Amendments

[81 FR 65280, Sept. 22, 2016]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[81 FR 65280, Sept. 22, 2016]