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Title 21 Part 886 → Subpart B → §886.1790

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1790

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1790

e-CFR data is current as of July 22, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1790


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§886.1790   Nearpoint ruler.

(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 requirements of the quality system regulation 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]