The FDA has published guidelines for managing a Design History file for a product. This applies to all Class II and Class III devices, and Class I devices with a software component.

Design History File Basics

The FDA states that
" Each manufacturer shall establish and maintain a DHF for each type of device. 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."

Next: Components of a DHF based on Device Type

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