eCFR Reference Browser

---

title: "21 CFR §820.130"

source: "https://www.ecfr.gov/current/title-21/section-820.130"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "820"

part_subject: "QUALITY SYSTEM REGULATION"

subpart_code: "K"

subpart_subject: "Labeling and Packaging Control"

section_number: "820.130"

section_subject: "Device packaging."

cfr_reference: "21 CFR 820.130"

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"

---

Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.

§820.130 - Device packaging.