Events

  • Smoldering Submission Issues: 510(k), PMA and DeNovo

    Tuesday, October 28, 2014 9:00am - Tuesday, October 28, 2014 12:00pm
    Category: Seminars
    Presenter: Mark DuVal

    DuVal & Associates and Medical Alley Association are pleased to offer a full-day program covering smoldering topics relating to submissions work, focusing on 510(k), PMA and De Novo.  These are current issues that everyone is asking questions about, and require group dialogue.  Our format will be to address each topic area, leaving time to fully engage the audience and our experts. The program will conclude with an open Ask-The-Experts interactive question and answer session.

  • Helping FDA Clear Your 510(k): Understanding FDA's Wants & Needs

    Thursday, October 16, 2014 7:30am - Thursday, October 16, 2014 5:00am
    Category: Seminars
    Presenter: Mark DuVal
    Organizer: 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. 

  • Marketing your Medical Device in the new FDA/OIG Enforcement Environment: Part 4 of 4

    Tuesday, October 7, 2014 11:00am - Tuesday, October 7, 2014 1:00am
    Category: Webinars
    Presenter: Mark DuVal
    Organizer: DuValEDU

    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.

  • Meeting Challenges in FDA 510(k) Review

    Tuesday, September 30, 2014 3:30am - Tuesday, September 30, 2014 5:00am
    Category: Conferences
    Presenter: Mark DuVal

    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.

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