FDA Intel

21 CFR 820.184: Device history record

Manufacturers had to maintain procedures and device history records for each batch, lot, or unit showing production followed the DMR, including manufacture dates, quantities made and released, acceptance records, labeling, and UDI or control numbers.

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 820.184, from the 483s we hold.

A device history record has not been adequately maintained.Most used
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
Procedures for device history records have not been established.

Cited over time

483s citing 820.184, by year

Most citations in 2022. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2022.

Recent 483s citing 820.184

See all 483s citing 820.184

The regulation text

§ 820.184 Device history record. As published before it was replaced.

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.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]

Questions

What does 21 CFR 820.184 require?

Manufacturers had to maintain procedures and device history records for each batch, lot, or unit showing production followed the DMR, including manufacture dates, quantities made and released, acceptance records, labeling, and UDI or control numbers.

How do FDA investigators word a 820.184 observation?

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

Which sections are cited alongside 820.184?

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