is being presented by Maria Shepherd & Kathleen
Whanger, President & Senior Quality Engineer, with Data Decision Group & Boston Scientific and airs on Thursday, May 10th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Draft Guidance for Industry and Food and Drug Administration Staff -
Applying Human Factors and Usability Engineering to Optimize Medical Device
Design was released by the FDA in June, 2011. It states that, as part of design
control, manufacturers must conduct a risk analysis to assess/mitigate risks
associated with device use. In addition, the FDA expects the manufacturer will
perform human factors engineering and usability testing as a part of the product
development process.
FDA takes these human factors requirements seriously, requiring a
systematic assessment that incorporates usability testing to determine how the
device will be used, the environment in which it will be used, and existing
use-related hazards. Under these circumstances, manufacturers should provide FDA
with a report that summarizes the human factors processes, evaluations, and
results of validation testing as part of their pre-market applications or
submission.
