What does the Design History File (DHF) contain?

The Design History File (DHF) is a critical component in the regulatory process for medical devices, as specified by the FDA. Its primary purpose is to document the design and development process of a medical device, ensuring that it conforms to the approved design specifications and regulatory requirements.

Specifically, the DHF includes a comprehensive record of the design, which encompasses the design plans, design inputs and outputs, verification and validation documentation, and the design changes that occur throughout the development lifecycle. This documentation enhances the ability to demonstrate compliance with regulatory standards, making it essential for fulfilling 21 CFR Part 820 requirements related to quality system regulations.

In contrast, the other options do not accurately capture the scope and purpose of the DHF. For instance, while a production history pertains to manufacturing aspects, this is documented separately in a different file. Descriptions of unfinished devices or concepts might be relevant to the initial brainstorming or early design phase but are not formally captured in the DHF. Similarly, communications with the FDA are important but are maintained in distinct records and correspondence files, rather than within the DHF. Thus, the correct answer reflects the comprehensive nature of the DHF as it pertains specifically to the finished device's design records.