Title 21 Part 886 → Subpart F → §886.5918

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart F → §886.5918

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart F → §886.5918

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

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5918

Title 21: Food and Drugs
Subpart F—Therapeutic Devices

§886.5918   Rigid gas permeable contact lens care products.

(a) Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

[62 FR 30987, June 6, 1997]