Design History File (DHF)

What is a design history file?

Under the FDA's historical Quality System Regulation at 21 CFR 820.30, each manufacturer had to establish and maintain a DHF for each device type: the records of design plans, inputs, outputs, reviews, verification, validation, transfer and design changes. The DHF answered a central inspection question — can the manufacturer show that the device was developed under design controls?

Did the QMSR change the DHF requirement?

It changed the regulatory vocabulary and structure. Since 2 February 2026 the QMSR incorporates ISO 13485, which requires a design and development file for each medical device type or family and a medical device file containing or referencing other product specifications and procedures. A legacy DHF may supply much of that evidence, but manufacturers should perform a documented mapping and gap assessment rather than assume the old folder automatically satisfies the incorporated standard and FDA-specific provisions.

What belongs in the design history evidence?

The design and development plan; design inputs including user needs and regulatory requirements; outputs and their acceptance criteria; results of design reviews; verification and validation protocols, data and conclusions — including software and usability evidence where applicable; risk management records under ISO 14971; transfer evidence; and the change history connecting those records. The exact organization can vary, but traceability and controlled records are essential.

When should a company start building it?

When regulated design and development begins, because later reconstruction cannot replace contemporaneous evidence. Submission reviewers and inspectors may trace product claims into the supporting design records. For companies targeting the United States, those records also provide source evidence for 510(k), De Novo or PMA content and for later change assessments.