eCFR Reference Browser

---

title: "21 CFR §820.160"

source: "https://www.ecfr.gov/current/title-21/section-820.160"

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: "L"

subpart_subject: "Handling, Storage, Distribution, and Installation"

section_number: "820.160"

section_subject: "Distribution."

cfr_reference: "21 CFR 820.160"

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)Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.

(b)Each manufacturer shall maintain distribution records which include or refer to the location of:

(1)The name and address of the initial consignee;

(2)The identification and quantity of devices shipped;

(3)The date shipped; and

(4)Any control number(s) used.

§820.160 - Distribution.