According to the Code of Federal Regulations (CFR), the device history record is a compilation of records containing the production history of a finished device. Section 21 CFR 820.184 states, each manufacturer shall maintain DHR’s and have procedures to ensure that each batch of device are maintained to show that the device is manufactured in accordance with the Device Master Record (DMR). Each DHR should include:
- The dates of manufacture
- The quantity manufactured
- The quantity released for distribution
- The acceptance records with demonstrate the device is manufactured in accordance with the DMR
- The primary identification label and labeling used for each production unit
- Any unique device identifier (UDI) or universal product code (UPC), and any other device identifications(s) and control numbers(s) used.
A company was recently cited for:
…. A device history record has not been adequately maintained.
a. DHR for … lot … noted the amount of … added to the … solution as …; however, this amount does not match the amount of … specified in the product’s formulation.
b. DHR for … lot … did not include a … QA Solution Preparation form.
c. DHR for… lot … did not include data for all QA tests performed during the product QA release process.
d. DHR for … lot … did not include data summarizing QA test results for product QA release.
These deficiencies were not identified as nonconformances. All DHRs were reviewed and approved.
For more information on device history records and the differences between DHF (design history file), DMR (device master records) and DHR (device history record) see FDA presentation, Documents, Change Control and Records and the transcripts to the presentation.
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