Human Factors to Play a Bigger Role in FDA’s Decisions about Medical Devices

Each year the medical device reviewers release the top 10 areas of priority for the coming year. For the coming year, CDRH’s list of top priorities includes increased emphasis on human factors in regulatory decisions. Of the 10 areas of priority, about 5 discuss review and evaluation of human factors in medical device design, approval and post-market safety analysis. FDA’s interest in human factor is diverse and multi-dimensional. FDA is interested in using big data from human genome database and clinical trials, incorporating human factor engineering issues regarding usability issues and preventable design problems, increased use of patient reported outcome measures, and collecting high quality patient experience data for making decisions that could reflect higher patient acceptance of medical devices. FDA has been asked to use big data recently by Congress. Similarly FDA has emphasized using patient reported outcomes in design and approval of products for several years. But by making these issues together as published areas of priority, FDA brings to the forefront of discussion. We should expect increased FDA comments on human factors in medical device decisions this year and in the immediate future.