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Title 21 Part 886 → Subpart B → §886.1380

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1380

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1380

e-CFR data is current as of September 13, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1380


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


§886.1380   Diagnostic condensing lens.

(a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

(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 38810, July 25, 2001]