eCFR Reference Browser

---

title: "21 CFR §886.1800"

source: "https://www.ecfr.gov/current/title-21/section-886.1800"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "886"

part_subject: "OPHTHALMIC DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "886.1800"

section_subject: "Schirmer strip."

cfr_reference: "21 CFR 886.1800"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.

(b)Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, 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.

§886.1800 - Schirmer strip.