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The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.“ There is also a definition for a DHF found in 21 CFR 820.3(e), “Design history file (DHF ) means a compilation of records which describes the design history of a ...

There is also a definition for a DHF found in 21 CFR 820.3(e), “Design history file (DHF ) means a compilation of records which describes the design history of a finished device.” The FDA provided an official interpretation of this requirement in the preamble when the QSR was published in 1996.

The architectural plans and engineering for this project were donated, and the surveys were done by student interns, DHfH staff and several Habitat families. DHfH screens potential buyers carefully, evaluating commitment and a willingness to work. DHfH provides an interest-free, 15-year, 25-year or 30-year mortgage, which it services in-house.

The FDA provided an official interpretation of this requirement in the preamble when the QSR was published in 1996. That discussion of the requirement indicated that the DHF is intended to be a repository of the records required to demonstrate compliance with your design plan and your design control procedures.