21 CFR 886.5810 — Reader, Prism, Ophthalmic

Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5810

Identification

An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

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