Newsletter - October 23, 2015
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. Read More..
Genetic Tests: Two Companies Different Stories
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 interesting case study of two companies developing identical technologies but drastically different regulatory strategies. Read More..
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. Read More..
Genetic Tests: Two Companies Different Stories
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 interesting case study of two companies developing identical technologies but drastically different regulatory strategies. Read More..
