Which document provides the production history of a medical device?

The Device History Record is the document that provides a complete production history of a medical device. It contains detailed information about the manufacturing process, including the dates of production, the individuals involved, the equipment used, and the outcomes of any inspections and tests performed during production. This record is crucial for ensuring compliance with regulatory requirements and for tracking the quality of the device through its production lifecycle.

This document serves as an essential part of the quality system regulation (QSR) outlined by the FDA, specifically under 21 CFR Part 820, which requires manufacturers to maintain detailed records to reflect the history of each product. Having a comprehensive Device History Record allows manufacturers to trace production issues and ensure that products meet safety and efficacy standards.

While the Design History File contains documentation related to the design and development process of a medical device and the Device Master Record details the specifications and procedures for creating the device, neither of these focuses specifically on the production history, which is the core purpose of the Device History Record. The Drug Master File, on the other hand, pertains specifically to pharmaceutical products and does not apply to medical devices.