subpart_subject: "Physical Medicine Prosthetic Devices"
section_number: "890.3675"
section_subject: "Denis Brown splint."
cfr_reference: "21 CFR 890.3675"
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"
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(a)Identification. A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.
(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 § 890.9. 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, regarding general requirements concerning records and § 820.198, regarding complaint files.