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Title 21 Part 886 → Subpart B → §886.1400

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1400

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1400

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1400


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


§886.1400   Maddox lens.

(a) Identification. A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.

(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 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001]