21 C.F.R. § 886.1790 Nearpoint ruler.
Title 21 - Food and Drugs
(a) Identification. A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum). (b) Classification. 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 regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988; 66 FR 38812, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1790 Nearpoint ruler.
