• Medical Device and Diagnostic Regulatory Breakout

    • On: January 26, 2015 at 01:01AM
    • Category: Conferences

    The Food and Drug Administration has openly commented on its objective to become more of a proponent and less of an obstacle for innovative pharmaceuticals and medical devices to enter the marketplace. However, the life science industry still views the regulatory approval process as a difficult path to navigate due to stringent requirements for clinical data, lengthy approval timelines and a lack of transparency from the FDA. To improve the relationship between manufacturers and the agency, a collaborative environment must be fostered through effective communication and an understanding of FDA's plans for transforming regulatory pathways into a catalyst for medical innovation.

  • The Pre-Submission Meeting: Friend or Foe?

    • On: November 5, 2014 at 09:11AM
    • Category: Conferences

    Device manufacturers, biodesign innovators, regulatory specialists, and academics register now for the 3rd Annual UGA Medical Device Regulations Conference! This conference, cosponsored by the US FDA and the University of Georgia’s Office of BioPharma Regulatory Affairs, will provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective.

  • Encouraging Communications & Transparency Between Industry and Regulators

    • On: November 4, 2014 at 08:11AM
    • Category: 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
    • 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. 

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Helping clients be appropriately aggressive, yet compliant. TM