• Helping FDA Clear Your 510(k): Understanding FDA's wants and needs

    • On: January 17, 2014 at 07:01AM
    • Category: Conferences

    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.   

  • Moving in the Right Direction: Regulatory Progress in Device Clearance & Approval

    • On: October 28, 2013 at 08:10AM
    • Category: Conferences

    Keynote speaker and panel moderator.

    Moving in the Right Direction: Regulatory Progress in Device Clearance & Approval

  • Regulatory Pains

    • On: October 16, 2013 at 08:10AM
    • Category: Conferences

    The MichBio Expo is the largest gathering of bioscience professoinal in Michigan, and MichBio as the industry trade association, endeavors to bring the most timely topics and experts to insure a top-notch program. This year, the theme is 'Bio-Growth through Bio-Innovation', and our Keynote Speaker will be Stelios Papodopoulos, PhD. Chairman of Exelixis. In additiong, the event will feature a Bio-Industry Town Hall, CEOs Unplugged session, multiple track sessions, facility tours, and a Biosciences Emerging Showcase for start-ups seeking investment.

  • 510(k) Delays: Is it FDA or Quality?

    • On: May 2, 2013 at 12:05PM
    • Category: Conferences

    MedCon 2013, Xavier University, Cincinatti, OH.

    Industry has ongoing concerns that the 510(k) review process continues to delay approvals and stifle innovation. This session will discuss FDA's recently released refusal to file guidance and common quality issues with 510(k) submissions. The discussion will include FDA performance metrics under the current regulations and changes implemented with MDUFMA III. An industry perspective will be presented using representative case studies.

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