part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "G"
subpart_subject: "General Hospital and Personal Use Miscellaneous Devices"
section_number: "880.6230"
section_subject: "Tongue depressor."
cfr_reference: "21 CFR 880.6230"
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 tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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.