Ophthalmic Devices
---
identifier: "/us/fr/03-55524"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Ophthalmic Devices"
title_number: 0
title_name: "Federal Register"
section_number: "03-55524"
section_name: "Ophthalmic Devices"
positive_law: false
currency: "2003-08-18"
last_updated: "2003-08-18"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "03-55524"
document_type: "rule"
publication_date: "2003-08-18"
agencies:
- "Health and Human Services Department"
- "Food and Drug Administration"
cfr_references:
- "21 CFR Part 886"
fr_citation: "68 FR 49351"
fr_volume: 68
---
# Headband mirror.
**CFR Correction**
In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2003, in § 886.1500, on page 456, paragraph (b) is added to read as follows:
§ 886.1500
(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 regulations 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.