21 CFR §886.1342

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (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. (2)Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated:
      1. (i)Verification of lowest detectable amount of deviation; and
      2. (ii)Validation of the accuracy and precision at the lowest detectable amount of deviation.
   3. (3)Software verification, validation, and hazard analysis must be performed.
   4. (4)Optical radiation safety testing must demonstrate the device is safe per the directions for use.
   5. (5)Performance testing must demonstrate the electromagnetic compatibility of the device.
   6. (6)Performance testing must demonstrate the electrical safety of the device.
   7. (7)Labeling must include the following:
      1. (i)Summaries of non-clinical and clinical performance testing;
      2. (ii)Instructions on how to correctly use and maintain the device;
      3. (iii)Instructions and explanation of all user-interface components; and
      4. (iv)Information related to electromagnetic compatibility and optical radiation classification.