• Encouraging Communications & Transparency Between Industry and Regulators

    • On November 4, 2014 at 08:11AM
    • Categorized in Conferences

    Effective communication with regulatory agencies throughout the clearance and approval process of a medical device continues to be a core challenge for regulatory affairs executives.

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

    • On October 16, 2014 at 07:10AM
    • Categorized in 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. 

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

    • On October 7, 2014 at 11:10AM
    • Categorized in Conferences

    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

    • On September 30, 2014 at 03:09AM
    • Categorized in Conferences

    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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