Knowing how to get yoru 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 will lead an omnibus program that will teach you the basics and advanced knowledge of the 510(k) and de novo programs.
Thursday, February 6, 2014 9:00am - Thursday, February 6, 2014 10:00amOrganizer: RAPS Atlanta Chapter
Wednesday, February 5, 2014 8:00am - Wednesday, February 5, 2014 4:00am
The Physician Payment Sunshine Act: Are You Ready to Report & React?
DuVal & Associates and Vector Health
ChicagoThe 1st-half of the program will be devoted to a detailed review of the final regulation and how it applies to your company. Attendees will learn the basics of the Sunshine Act. Topics include: collection of data, registering your company, reporting (and the exceptions), certification/attestation of data, verification of data with customers, correction of data, creation of an “assumptions” document, among other things. Importantly, there are many exceptions you need to know about. Not knowing the exceptions, and how they apply, will put you at a competitive disadvantage in the marketplace.
Thursday, January 30, 2014 9:00am - Thursday, January 30, 2014 10:00amOrganizer: Q1 Productions
In recent years, FDA has released numerous draft guidances to streamline the review process, elevate the level of scrutiny placed on submissions and ensure the safety and efficacy of devices.
Friday, January 17, 2014 7:30am - Friday, January 17, 2014 5:00amCategory: SeminarsOrganizer: DuValEDU
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.