Traceability in Device Design

Traceability in Device Design, Development, and Distribution

In FDA, Preclinical by Angela Mallery

The path through medical device design, testing, application, and maintenance needs to be traceable. Traceability analyses aid in understanding device design and whether requirements are being met. According to FDA, “A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations.”

Once a manufacturer decides on a product, they will need to start developing a plan, or the design input with its intended use, function, and performance requirements. Without complete and thorough design inputs, a product can run into performance issues. After the design inputs are created, an assessment is conducted, during which the conditions of the device’s operation are identified. Testing is conducted based on the pre-specified design input requirements which then yields design outputs. Upon design verification completion, these outputs become the inputs for the next step, design validation, as shown in Figure 1. Design reviews are conducted throughout the development process to allow for incremental changes and to verify that the device is capable of moving forward with development.


Figure 1 from FDA Design Control Guidance for Medical Device Manufacturers. Available at:

It is important to begin the design control process when a product is first being developed in order to ensure that design outputs are traceable to design inputs. Traceability is intended to control the design process and to ensure than the device meets user needs, intended uses, and the specified requirements. This will facilitate risk mitigation and device testing as well as help prove device safety, efficacy, and compliance. A clear and effective approach to traceability is still being debated. The goal is to have a rationale and data supporting the device through all phases of development and beyond. The design inputs and outputs should be documented to confirm that the outputs are traceable to the inputs. A design history file should be maintained to demonstrate adherence to federal requirements (21 CFR 820).

Traceability in medical device design ensures that a protocol is followed and that there is appropriate documentation to support device efficacy and safety. It is important to maintain a traceability initiate throughout device design, testing, and distribution and to involve a cross-functional team to carry it out.

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US Food and Drug Administration. Design Control Guidance for Medical Device Manufacturers. March 11, 1997. Available at:

US Code of Federal Regulations. 21 CFR 820. Quality System Regulation. Available at:


Angela Mallery EdD, has over 25 years of experience working in device regulatory affairs in small, medium and large sized companies. Angela is a project manager and regulatory consultant for NAMSA on worldwide device regulatory registrations; including cardiac and peripheral devices, tissue products and urology devices. She also holds an adjunct faculty position at St. Cloud State University, teaching in the regulatory program.