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

---
identifier: "/us/cfr/t21/s801.122"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.122 - Medical devices for processing, repacking, or manufacturing."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.122"
section_name: "Medical devices for processing, repacking, or manufacturing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "801"
part_name: "LABELING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.122 Medical devices for processing, repacking, or manufacturing.

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”.