Integra Systems assists major medical device company in wireless testing and approval in record time!

www.integrasystems.org most recently (February of 2011), completed authorship of test plans and protocols for wireless testing for a multi-mode wireless enabled medical device. In March with our partners we completed the testing and provided the output documentation (100 plus pages), back to the medical device company for the pre- FDA 510k submittal. In between there were some questions that the reviewer had of which we addressed. We are very happy to report that the major medical device company actually received last full FDA approval last week! FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510k clearance rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seen to be getting tougher than in the recent past.