Device History Records – Streamlining Compliance With eDHR

By Patrick Lemay, Tulip

To successfully bring medical devices to market in the United States, manufacturers must obtain approval from the Food and Drug Administration (FDA). A critical component of both securing and maintaining this approval is the creation and upkeep of a detailed and comprehensive Device History Record (DHR). This record serves as a vital link between the manufacturing process and regulatory compliance, documenting that each device has been produced in accordance with the specifications outlined in the Device Master Record.

The DHR includes a wide range of product-specific data, such as production dates, quantities, labeling, and inspection results, all of which demonstrate that the device meets the required standards. The FDA mandates this documentation through Title 21 of the Code of Federal Regulations (CFR) Part 820.184, which outlines the expectations for quality system regulation in medical device manufacturing. By adhering to these guidelines, manufacturers not only ensure product integrity and patient safety but also position themselves to meet industry standards and regulatory scrutiny.

If you're a medical device manufacturer, now is the time to evaluate your DHR processes. Ensuring your records are complete, accurate, and compliant can make all the difference in achieving FDA approval and maintaining market access.