Standards / Guidances

Pre-market SubmissionsThe links below will direct you to the current standards and guidances.  These are essential to understanding the Human Factors and Usability process for medical devices.

Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Medical Devices

Released on February 3, 2016, this is the final version of FDA’s Center for Devices and Radiological Health human factors guidance to industry concerning the process of human factors recommended by FDA/CDRH, and very helpful descriptions of reviewer expectations for pre-market human factors review content and reporting.  Helpful examples have been added to guide industry human factors and usability efforts in providing the needed evidence to substantiate use safety and effectiveness for medical devices.  Other additions include a slightly new structure for the Human Factors/Usability Report in Appendix A.

FDA Combination Product Testing Guidance.  On February 3, 2016, the FDA Office of Combination Products (OCP)  released a draft industry guidance on testing of combination products. The draft guidance covers testing requirements for both combination products and instructions for use (IFUs).

List of High Priority Devices for Human Factors Reviews.  The FDA Center for Devices and Radiological Health issued a draft guidance to industry on February 3, 2016 regarding certain medical devices that have been classified as having high priority regarding the reporting of human factors testing and analysis in pre-market submissions.  The guidance includes advice on determining whether devices that were not included on the priority list will require human factors as an element in pre-market reviews for approval or clearance determination.

What if my device is not on this list?  What’s required for Human Factors?  We are often asked, “what if my device is not on the priority list for human factors at FDA?  Am I still required to conduct a simulated use validation test of the user interface?  This question is dependent on your use risk profile.  If your device or device family has a history of use problems in post-market reports, or there are critical tasks during user-device interaction that, if performed incorrectly could lead to direct or immediate user/patient harm, you will likely be required to do human factors testing.  Always, it is in your best interest to conduct use risk analyses and formative testing of your user interfaces and document these in the Human Factors/Usability Engineering report outlined in Appendix A of the guidance.

Medical Devices – Application of Usability Engineering To Medical Devices – IEC 62366: 2007

This standard is under current revision and will be divided into “normative” and “informative” sections.  It is being reissued under IEC 62366: 2015-1 (Normative) and ICE 62366: 2015-2 (Informative) nomenclature.  The Normative document contains the standard “shall” statements for manufacturer compliance, while the Informative document contains many examples of the intent of the Normative version and practical explanations of concepts and clauses of the Usability Engineering Process.

Human Factors Engineering – Design of Medical Devices – AAMI HE75: 2009

This is the medical industry oriented design best practice for all aspects of device user interface design and usability testing of device displays, controls, workstations, software UIs, surgical tools, mobile devices, automated devices, instructions for use, etc.

Safety Considerations for Product Design to Minimize Medication Errors

Present’s FDA’s current thinking on the need to perform use-related risk assessments early in combination or drug product design and apply formative and summative usability testing in the design process to optimize the design for risk prevention and drug administration efficacy. This guidance espouses many human factors methods and principles in drug product design and cites the CDR Human Factors Draft Guidance to Industry as the accompanying resource for human factors.

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

This guidance focuses on common problems in the design of drug container and labeling that induce critical medication errors such as poor legibility of safety information, and inability to differentiate dosages of a drug from the container labels. The application of cognitive engineering and human factors methods are emphasized in efforts to reduce risk of medication errors by these design factors.

Best Practices in Developing Proprietary Drug Names to Minimize Medication Errors

Presents FDA’s current thinking on developing and choosing proposed drug names based on current practice for eliminating or reducing name confusion.