What document must manufacturers maintain to ensure compliance with FDA regulations?

The Design History File (DHF) is a crucial document that manufacturers must maintain to ensure compliance with FDA regulations, particularly for medical devices. The DHF serves as a comprehensive record that demonstrates the design and development process of a medical device. It contains all the documents and records that are generated throughout the design phase and provides evidence that the device was developed according to the approved design plan, meeting both regulatory requirements and quality standards.

The importance of maintaining a DHF lies in its role during regulatory inspections and audits. It allows regulatory authorities to verify that the manufacturer's design control process aligns with the FDA's Quality System Regulation (QSR) requirements. The DHF must include design plans, design input documents, design output documents, design verification and validation records, and any changes made throughout the design process. Having this documentation not only facilitates product approvals but also enhances the overall quality and safety of the device being manufactured.

While the Quality Management System (QMS) is essential for overarching quality assurance and compliance framework within an organization, the DHF specifically addresses the design aspect, making it a critical focus for manufacturers in demonstrating their adherence to FDA regulations. The Product Requirement Document (PRD) and the Technical File (TF) are important documents in their own right,