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e-CFR data is current as of September 16, 2020

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1880


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


§886.1880   Fusion and stereoscopic target.

(a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (§886.1870).

(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 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

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