Device History Record Legacy term

A record the Quality System Regulation required to show that each batch, lot, or unit was made in accordance with its device master record. Its content now sits largely in the medical device file or the batch record under ISO 13485 clause 7.5.1.

Replaced by

Largely the medical device or batch record under ISO 13485:2016 clause 7.5.1, with the UDI recorded for each device or batch under 21 CFR 820.35(c)

Where the replacement is written

ISO 13485:2016 clause 7.5.1; 21 CFR 820.35(c); 89 FR 7496, response to comment 31

Old rule

21 CFR 820.184, in Part 820 before February 2, 2026

Also called

DHR

Related terms