Consultants Specializing in Regulatory Affairs for FDA Compliance

Human Factor Study and Performance Testing

The FDA’s focus on HFE/UE (Human Factor Engineering and Usability engineering) validation and risk mitigation affected by a device design and user manual has resulted in an increased need for Human Factor Studies. As part of risk management in the design phase and with the final finished product, only use by the intended user can verify the mitigation of risk and validate the safe use of your design. Smith Associates’ simulated use studies by the lay person and the professional have assisted many of our clients in their 510k submission. Our study groups include the range of study participants from the professional to the lay user. Visit us on facebook.

For the results of the human factors validation testing to demonstrate safe and effective use by users in the United States, the participants in the testing should reside in the US. Studies performed in other countries or with non-US residents may be affected (positively or negatively) by different clinical practices that exist in other countries, different units of measure used, language differences that change the way labeling and training are understood.
FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices

HUMAN FACTORS AND DESIGN CONTROL

As part of Design Control and Risk Analysis, the user interface as validated by the intended user is a necessary part of design control activities and eventually a part of the 510k submission process, either traditional or modification. Mitigation of user error by product design and User Manuals can only by verified by the intended user in their use environment. User error is considered a nonconformity and is appropriately addressed under design control before the final human factor study which will be final verification of the mitigation of potential risks of misuse by the intended user.

HUMAN FACTORS/USABILITY AND THE 510K SUBMISSION

Human Factor Studies that may include usability, user manual review, simulated use in the clinical setting, or by the lay user in the home setting, is becoming a more common requirement in 510ks and in vitro diagnostics. The home user of medical devices or in vitro diagnostics devices that may be prescribed by the physician or purchased over the counter are now part of the final validation of your device's use and user instruction. FDA is also requiring user verification of instructions in the hospital setting or physician setting for certain classifications of devices, or for user interface innovations in old technology.

HUMAN FACTORS SERVICES FOR HF/USABILITY AND HF/LABEL COMPREHENSION

Smith Associates has been writing protocols, case report forms and administrative plans for 510k Human Factors/Usability Studies and IDE submissions clinical trials since the late 90’s and actually conducting human factors/usability and simulated use studies since 2002. Our extensive experience includes:

  • Preparation of protocols, case report forms and Administrative plans for IDEs (Investigational Device Exemption) for human clinicals;
  • Preparation of protocols, case report forms for Human Factor/Usability studies, and simulated use in the clinical environment;
  • Submit protocol to the FDA via the Pre Sub, if required;
  • Recruit the appropriate study participants (Adult, Adolescent and Pediatric lay users) for your lay user study from our extensive database of lay users;
  • Recruit the intended user clinicians for Simulated Use study to validate safe use by intended user;
  • Recruit appropriate study participant for a disease specific study (e.g. diabetic patients for s User Performance or Accuracy study for BGMS);
  • Conduct the study in the required use environment;
  • Study conducted by experienced study staff to ensure protocol requirements are met;
  • Training for study participants as required for product type;
  • Collect and organize all study data;
  • Prepare the final report for the design control verification or for a 510k submission or PMA;

Our Human Factor Studies have included OTC monitoring devices and in vitro diagnostic devices, such as blood glucose devices, spirometers, massagers, cardiac monitors, low level lasers, patient phone and computer interface apps. Clinical studies have included clinician phone, tablet and computer interface products besides performance testing for hospital use devices, such as safety syringes, safety catheters, sharps containers and safety blood collection devices, negative pressure wound devices, and an ever increasing number of Class II devices.

The following is FDA's definition of the Simulated Use Testing:

"Simulated use testing (also called usability testing and, occasionally, user testing) involves systematic collection of data from users (participants) using a device (or device component or system) in realistic situations. Data are obtained in a variety of ways, including subjective user feedback, manual and automated measures of user performance, and direct observation."

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