Establishing and Maintaining the Device History Record
This concludes our series on Medical Device Development documentation required by the FDA: the Design History File (DHF), the Device Master record (DMR) and the Device History Record (DHR). You can read more about the Design History File here and the Device Master Record here.
The Device History Record is the proof that the product was manufactured in accordance with the DMR. The DHR can easily be tailored to a device manufacturer’s specific needs, providing all of the information required is included, such as:
The date of manufacture
The quantity manufactured
The quantity released to distribution
The Acceptance records which demonstrate the device is manufactured in accordance with the DMR
The primary identification label and labeling used for each production unit
Device identification number
Optionally, include:
A reference to each of the inspection and test procedures used
The names of individuals performing each of the process steps and the dates the process steps were performed
The name of the individual responsible for releasing the lot/batch for distribution
A device manufacturer employing a contract manufacturer is still responsible for the DHR. It should be clear who will be receiving, reviewing, and approving the DHR including authorizing the release of finished medical devices. A DHR Procedure and checklists will help ensure the DHR meets the requirements of the FDA Quality Systems Regulations for Medical Devices. From design to production, the supporting documentation must be complete and compliant with FDA requirements.