US FDA 510(k): How to Put Together a Compelling 510(k): Good Practices with Increased Awareness

This webinar is intended to demonstrate how to put together a compelling (bullet proof) 510(k) in compliance with the FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to expedite your 510(k) clearance, potentially leading to saving millions. In September, 2013, FDA has cleared 211 devices (510(k)s) under the 510(k) program.  Among those, there were nine (9) abbreviated and 41 special 510(k)s.   Two of these 510(k)s were initially submitted in the middle of the year 2011. 

Although it is believed there are various factors contributing to timing of 510(k) clearances, it is imperative more than ever from our industry perspectives that the medical device manufacturers understand recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to expedite the review process and successful clearance without delays.