Cautious FDA Is Obstacle For Burgeoning Diabetes Device Market

Article preview from Medtech Insight - August 1, 2011

Is innovation in the diabetes device market being hampered by a slowdown in FDA approvals? That question was the unofficial, under-riding theme at the American Diabetes Association 71st Scientific Sessions in June.

Cautious FDA Is Obstacle For Burgeoning Diabetes Device Market

Article preview from Medtech Insight - August 1, 2011

The diabetes market is full of innovation. The large, worldwide patient population offers opportunities for established as well as new companies that can produce effective new treatments or improve on existing methodologies. Even in the down economy, a number of companies are eager to invest the time and money to develop cutting edge technology to battle a disease that has reached epidemic status in some countries. However, many now believe there is a glaring obstacle in moving innovation from development to actual clinical usage in the US as approvals by the US Food & Drug Administration (FDA) have noticeably slowed compared to overseas markets.

Of course, criticism of the FDA is certainly not a new development, and medical device manufacturers from across the health care spectrum have complained about the speed of FDA approvals at one time or another. But a study recently released by the consulting firm Emergo Group shows FDA review times for some medical devices jumped substantially between 2006 and 2010. Emergo looked at the number of submissions the FDA clears each year and the average time it takes to receive approval for a 510(k) submission. The company found that the average 510(k) clearance time rose 38% over the study period, from 96 days in 2006 to 132 days in 2010.

Continued...

To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Medtech Insight Newsletter.

About Medtech Insight

Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices.