• Marketing your Medical Device in the new FDA/OIG Enforcement Environment Part 2

    • On July 8, 2014 at 11:07AM
    • Categorized in Conferences

    Part II will drill down into how FDA is regulating advertising and promotion for 510(k) devices and will cover in-depth FDA’s General/Specific Use guidance and how it is actually being interpreted today in 510(k) submission discussions and enforcement matters.

  • Marketing your Medical Device in the new FDA/OIG Enforcement Environment Part 1

    • On June 10, 2014 at 11:06AM
    • Categorized in Conferences

    Marketing a medical device today is getting increasingly complicated and requires an increasingly sophisticated knowledge-base and skill set for executives, compliance, legal, marketers, sales management, field sales, regulatory affairs and clinical affairs professionals.

  • FDA Device Clearance Process

    • On May 14, 2014 at 09:05AM
    • Categorized in Conferences

    Companies seeking medical device market approval and clearance often encounter roadblocks when it comes to submissions.

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

    • On April 3, 2014 at 07:04AM
    • 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. 

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Helping clients be appropriately aggressive, yet compliant. TM