21 CFR 886.1150 — Chart, Visual Acuity

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1150

Identification

A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes