The United States Food and Drug Administration (FDA) introduced the Design Control requirements for medical devices as part of the Safe Medical Device Act passed in 1990. The Design Controls are a set of procedures to ensure that the design of a medical device is safe, effective and meets the user requirements throughout the device lifecycle. The FDA mandates that the manufacturers of Class II, Class III and selected Class I devices implement Design Controls and maintain a Design History File (DHF) as per the Code of Federal Regulations (CFR) Title 21 Part 820.30. The creation of a DHF is the last step in the design control process. The DHF consists of a set of documents or records that demonstrates the design is developed in accordance with the Design and Development Plan and describes the design history of a finished medical device. The current Good Manufacturing Practice (cGMP) considers the DHF documents as living/dynamic documents as they are continuoulsy updated throughout the device lifetime as major changes are introduced.
A Legacy device is a medical device that is already in the market and developed several years ago pre-dating an applicable regulation. The Legacy devices may/may not have sufficient documented evidences to demonstrate compliance with all the applicable Design Control requirements. This white paper provides an approach for the creation/remediation of DHFs for legacy medical devices by leveraging the existing documents of legacy devicesby identifying the gaps in every design control elements.