FDA / 21 CFR 820

21 CFR 820 FDA Design Control Requirements

 

  • Establish and maintain procedures to control design of the device.

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  • Design and Development Planning – Each manufacturer shall establish a plan that describes the design and development activities, and defines responsibilities for implementation.

  • Design Inputs – Manufacturers need to ensure design requirements relating to a device are appropriate and address the intended use of the device.

 

  • Design Outputs – Design outputs need to be documented in terms that allow an adequate evaluation of conformance to design input requirements. Design outputs that are essential for the proper functioning of the device should be identified.

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  • Design Review – Formal documented reviews of design results should be planned and conducted at appropriate stages of device development.

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  • Design Verification – Design verification confirms that the design output meets the design inputs requirements.

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  • Design Validation – Design validation shall be performed under defined operating conditions on initial production units or their equivalents, and shall ensure that devices conform to defined user needs and meet the intended use of the device.

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  • Design Transfer – Design transfer documentation shall ensure that the device design is correctly translated into production specifications.

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  • Design Changes – changes should be identified, documented, validated/verified, reviewed and approved before their implementation.

 

The Design History File is intended to be a repository of the records required to demonstrate compliance with your design plan and design control procedures. While companies are required to create, and maintain this documentation according to the FDA regulation, not all of the documentation will be reviewed as part of the 510k.

Importance of Risk Analysis

For the purposes of FDA compliance and CE Marking, both recognize ISO 14971 as the standard for risk management. FDA recognizes ISO 14971:2007 and EN ISO 14971:2012 is the European National version for CE Marking.