eCFR Reference Browser

---

title: "21 CFR §890.3500"

source: "https://www.ecfr.gov/current/title-21/section-890.3500"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "890"

part_subject: "PHYSICAL MEDICINE DEVICES"

subpart_code: "D"

subpart_subject: "Physical Medicine Prosthetic Devices"

section_number: "890.3500"

section_subject: "External assembled lower limb prosthesis."

cfr_reference: "21 CFR 890.3500"

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. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

§890.3500 - External assembled lower limb prosthesis.