Stay Up-To-Date With Industry Happenings

Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.

We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.

We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.

  • FDA Town Hall Meeting With Dr. Shuren - May 18, 2010 - Minneapolis, MN

    • Authored by: Mark DuVal
    • Published on: May 19, 2010

    In this Client Alert, we offer our views on the FDA Town Hall meeting held May 18, 2010 in Minneapolis along with a battery of resources including a video of Congressman Erik Paulsen speaking yesterday from the House Floor about the Town Hall meeting.

    Observations

    It is clear that we have a strong leader at the helm at CDRH. Dr. Jeff Shuren displayed a firm grasp on the issues and challenges and has a clear idea how to solve them. He has clarity of insight and vision. He openly, calmly and candidly addressed questions with warmth and well-placed humor. He is an effective leader and spokesman for the Agency and extremely organized and driven.

  • New Firm Website And Minnesota Medical Device Alliance Coalition Announcement

    • Authored by: Mark DuVal
    • Published on: March 1, 2010

    In this Client Alert, we announce the launch of our new website. We also introduce the Minnesota Medical Device Alliance and provide an overview of recent events which relate to the 510(k) Program. NEW WEBSITEWe've recently created a new website for the firm. Visit us online at DuVal & Associates, FDA Law & Regulatory Affairs Consultants.

    New firm website

    DuVal & Associates is proud to unveil our new firm website at http://duvalfdalaw.com. Stay tuned here and subscribe to our Client Alert mailing list to keep up-to-date with industry happenings, firm news, our latest events, and more.

    Minnesota Medical Device Alliance

  • Practical Ways That Medical Device Companies Can Lawfully Communicate About Their Products Prior To FDA Clearance

    • Authored by: Mark DuVal
    • Published on: December 14, 2009

    In this Client Alert, we list practical ways medical device companies can lawfully communicate about their products prior to FDA clearance or approval. We encourage you to consider these activities when developing your pre-launch strategy. We hope this Client Alert helps you avoid common pre-product launch legal pitfalls.

    Executive summary

    There are many pre-clearance/approval activities a medical device company can lawfully engage in prior to attaining their 510(k) clearance/approval of a medical device. This Client Alert provides insight into these activities.

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM