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Title 21 Part 886 → Subpart E → §886.4750

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart E → §886.4750

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart E → §886.4750

e-CFR data is current as of June 17, 2019

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4750


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§886.4750   Ophthalmic eye shield.

(a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

(b) Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. When made only of plastic or aluminum, the devices are 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 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000]