Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients. He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program. This event will help attendees have a more solid foundation for understanding the 510(k) program while giving them the tools and insights, tips and tricks needed to obtain a 510(k) that is more likely to get cleared in a timely fashion.
Thursday, October 16, 2014 7:30am - Thursday, October 16, 2014 5:00am
Tuesday, October 7, 2014 11:00am - Tuesday, October 7, 2014 1:00am
Part IV will be a graduate-level course in the Anti-kickback Statute, False Claims Act (as it relates to reimbursement), Foreign Corrupt Practices Act (tangentially) and the Physician Payment Sunshine Act and how they all relate to one another.
Tuesday, September 30, 2014 3:30am - Tuesday, September 30, 2014 5:00amOrganizer: Austin Convention Center
The success of medical device firms is predicated upon incremental improvement of medical technology. New or modified devices are introduced onto the market through the 510(k) process.
Tuesday, July 8, 2014 11:00am - Tuesday, July 8, 2014 1:00am
Part II will drill down into how FDA is regulating advertising and promotion for 510(k) devices and will cover in-depth FDA’s General/Specific Use guidance and how it is actually being interpreted today in 510(k) submission discussions and enforcement matters.