BACK TO GLOSSARY

Device History Record Definition

A device history record (DHR) refers to a compilation of records containing the production history of a finished device and is defined under Subpart M 21 CFR Part 820 (Section 820.184). Section 820.184 states, “Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs 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
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used

Related Articles

• Good Design Controls Are Critical to Avoid FDA Issues
• Whitepaper: Strong Design Controls
• How Apical Instruments Streamlined and Improved Design Controls
• Design Controls – Drive Compliant Product Design Controls

External Resources

• CFR – Code of Federal Regulations Title 21
• The Importance of DHF, DMR, and DHR
• InstantGMP: Device History Record
• Clarifying Device History Record Issues