Title 21 Part 886 → Subpart B → §886.1390

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1390

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1390

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1390

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§886.1390   Flexible diagnostic Fresnel lens.

(a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens 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 38811, July 25, 2001]