FAQs
Inspection Readiness & Quality Systems

Q7: What is a Design History File and what does FDA expect to see in it?

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The Design History File (DHF) is the collection of records that documents the entire design and development history of a medical device. This includes everything from initial user needs through design inputs, outputs, verification, validation, and every subsequent design change. Within U.S. regulatory guidance, 21 CFR Part 820.30 outlines design controls for medical devices. It states that the DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan.

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FDA investigators approach a DHF review as a traceability exercise. Typically, they will pick a requirement or labeling claim and follow a documented chain forward, starting with user need and flowing through design input, design output, and verification evidence. A gap at any point in that chain is a potential 483 observation, an official notice of a condition that may violate FDA regulations.

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The most common DHF gaps that generate 483 observations include: design inputs that are too vague to verify, verification reports that don't reference the protocol executed, design changes without formal change control records, and labeling not treated as design output. Landrich Group's DHF gap assessment is designed to find these before FDA does.