eCFR Reference Browser

---

title: "21 CFR §892.6500"

source: "https://www.ecfr.gov/current/title-21/section-892.6500"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "892"

part_subject: "RADIOLOGY DEVICES"

subpart_code: "G"

subpart_subject: "Miscellaneous Devices"

section_number: "892.6500"

section_subject: "Personnel protective shield."

cfr_reference: "21 CFR 892.6500"

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 personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

(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 § 892.9.

§892.6500 - Personnel protective shield.