eCFR Reference Browser

---

title: "21 CFR §801.122"

source: "https://www.ecfr.gov/current/title-21/section-801.122"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "801"

part_subject: "LABELING"

subpart_code: "D"

subpart_subject: "Exemptions From Adequate Directions for Use"

section_number: "801.122"

section_subject: "Medical devices for processing, repacking, or manufacturing."

cfr_reference: "21 CFR 801.122"

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 device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”.

§801.122 - Medical devices for processing, repacking, or manufacturing.