eCFR Reference Browser

---

title: "21 CFR §820.184"

source: "https://www.ecfr.gov/current/title-21/section-820.184"

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: "M"

subpart_subject: "Records"

section_number: "820.184"

section_subject: "Device history record."

cfr_reference: "21 CFR 820.184"

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 maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a)The dates of manufacture;

(b)The quantity manufactured;

(c)The quantity released for distribution;

(d)The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e)The primary identification label and labeling used for each production unit; and

(f)Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

§820.184 - Device history record.