Submitted by kBLASTER Team on
by Jof Enriquez for Med Device Online
The U.S. Food and Drug Administration (FDA) claims it has approved medical devices markedly faster in the last five years than in the preceding decade. The agency attributes the improvement to its decades-old mandate, as well as more recent actions designed to facilitate approvals.
"These improvements include those to 510(k) and premarket approval (PMA) review times along with a reduction in Investigational Device Exemption (IDE) review times of almost a full year — which means many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Performance in FDA's review of novel, moderate risk devices has also improved markedly, demonstrating the success of FDA's efforts to expand use of its de novo review pathway," states the FDA report.
The FDA says total times to decision for device submissions have been reduced as follows:
- 510(k)s: From 132 days in 2010, lowered 13 percent to 115 days in 2014
- PMAs: From 352 days in 2009, lowered 31 percent to 242 days in 2014
- IDEs: From 442 days, decreased by over a year to 30 days in 2015
- De novo requests: From 992 days in 2010, lowered to 300 days in 2014
FDA also reports that the percentage of approved 510(k)s rose from 73 percent in 2010 to 84 percent in 2014, while the percentage of cleared PMAs jumped from 59 percent in 2010 to 86 percent in 2014. Pending submissions for 510(k)s decreased by 30 percent (from 1917 total pending in 2010 to 1385 in 2014), and for PMAs by 43 percent.
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