What are Design History File Requirements?

What are Design History File Requirements?

The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into the medical device manufacture worked in a preset process to arrive at the final product.

DHF requirements are an important component of the DHF. The DHF, a strict requirement from the FDA, is essentially meant to show conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is there to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. In other words, it eventually proves design control elements.

The US FDA states that DHF requirements need to be met. What are these requirements? The purpose of having specified DHF requirements is to ensure that user needs are met. It lists out a series of parameters that need to be met in order to ensure that these DHF requirements were met. These are:

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning
  • Design input
  • Design output
  • Design changes
  • Design review(s)
  • Design verification/validation
  • Design transfer
  • Design history file

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