Pre / Post Device History Records (DHR)

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. 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 device identification(s) and control number(s) used.

Ensure all DHR’s are complete in accordance to Good Documentation Practices (GDP) (DHR).

Avoid FDA 483: Failure to maintain device history records (DHR's) as required by 21 CFR § 820.184.  Ensure that the device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality System regulation.