eCFR Reference Browser

---

title: "21 CFR §820.181"

source: "https://www.ecfr.gov/current/title-21/section-820.181"

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: "820.181"

section_subject: "Device master record."

cfr_reference: "21 CFR 820.181"

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 master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a)Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b)Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c)Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d)Packaging and labeling specifications, including methods and processes used; and

(e)Installation, maintenance, and servicing procedures and methods.

§820.181 - Device master record.