Day: October 23, 2015

In the last 4 weeks, two things happened in the genetic diagnostic kits. The genetic diagnostic kit developed by 23 and Me got approval from FDA, albeit for a much more specific area than the company wanted. And Pathway Genomics got a letter from FDA asking to stop selling its cancer genetic diagnostic kit. This story is an … Read more

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 … Read more