The Food & Drug Administration falls far short of its own goals for clearing
medical device 510(k) clearance applications, according to an exclusive report
from MassDevice.com.
BOSTON--(Business Wire)--
According to MassDevice.com, the online business journal of the medical device
industry, medical device approval times under the Food & Drug Administration's
510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's
exclusive investigation of 10 years of FDA data, Eye on the FDA: H1 2009, shows
that approval times for medical devices increased nearly 2 percent - while the
number of 510(k) applications declined more than 19 percent - even as the FDA's
budgets and staff levels rose.
In fact, contrary to its own goal of clearing 90 percent of 510(k) applications
for medical devices in 90 days, Eye on the FDA: H1 2009 demonstrates that
decision times are trending significantly longer. For example, the average
decision time for 510(k) approvals was 113 days in 2008, compared with 87 days
in 2005, an increase of 30 percent in just three years.
"Medical device manufacturers should reconsider all timelines associated with
the 510(k) clearance process for medical technology," said MassDevice Publisher
Brian Johnson. "Taking into account a new, more stringent approach on the part
of the FDA's new leadership and a comprehensive institutional examination of the
510(k) process that will likely result in recommendations for change, the
regulatory path for new devices is likely to become longer, more costly and more
onerous in the near future."
Eye on the FDA: H1 2009 examines other key trends and data on the FDA's 510(k)
approvals process. Here's a small sampling:
* Average decision times for 510(k) clearances
* Average decision times by device classification
* 10-year history of 510(k) clearance decision times and device
classifications
* A list of all the companies and devices that received 510(k) approvals
during H1 2009
* The most active geographic regions for 510(k) approvals, by device
classification
* Hottest sectors and device classifications
MassDevice's new report, Eye on the FDA: H1 2009, provides important insight
into the trends shaping how most medical devices make it into the marketplace.
About MassDevice.com
MassDevice.com (www.MassDevice.com) is the online business journal of the
medical devices industry. The company provides daily coverage and in-depth
analysis of the trends and issues driving the sector.
MassDevice.com
Brian Johnson, 617-358-5632
Publisher
publisher@massdevice.com
Copyright Business Wire 2009
