FDA Intel

21 CFR 820.181: Device master record

Required manufacturers to maintain a device master record for each device type, approved under document controls, containing or referencing device, production process, quality assurance, packaging and labeling, and installation, maintenance and servicing specifications.

Part 820, Quality System Regulation · Subpart M, Records

Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.

How FDA words it

The opening lines investigators use most when they cite 820.181, from the 483s we hold.

A device master record has not been maintained.Most used
A device master record has not been adequately maintained.

Cited over time

483s citing 820.181, by year

Most citations in 2019. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2019.

Recent 483s citing 820.181

See all 483s citing 820.181

The regulation text

§ 820.181 Device master record. As published before it was replaced.

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.

Questions

What does 21 CFR 820.181 require?

Required manufacturers to maintain a device master record for each device type, approved under document controls, containing or referencing device, production process, quality assurance, packaging and labeling, and installation, maintenance and servicing specifications.

How do FDA investigators word a 820.181 observation?

The most common opening is: “A device master record has not been maintained.”

Which sections are cited alongside 820.181?

In the same 483s, investigators most often also cite 820.30 (Design controls), 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.50 (Purchasing controls).