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.

  • Dotting The I's And Crossing the T's

    • Authored by: Mark DuVal
    • Published on: August 1, 2015

    Executive summary

    Will your 510(k) submission withstand acceptance review? Acceptance review is not the point where you are through the front door of FDA and being asked whether your device is substantially equivalent. Instead, you are at the front door and asking whether you have dotted the i's and crossed the t's in your submission. Acceptance review is only about deciding whether your submission is complete.

  • David (Ivy Sports) Beats Goliath (FDA)

    • Authored by: Mark DuVal
    • Published on: September 26, 2014

    Executive summary

    © DuVal & Associates

    FDA again misjudged its strength and position in the little principled warrior, Ivy Sports Medicine, LLC, whose predecessor was ReGen Biologics, came out victorious.

    In this epic battle Ivy Sports is a small company, seemingly ill-equipped to do battle with the giant, FDA. But Ivy Sports stood up to FDA and knocked it down and out by winning a landmark case in the Federal Circuit Court of Appeals for the District of Columbia.

  • Open Letter To Office Of Device Evaluation Director Christy Foreman

    • Authored by: Mark DuVal
    • Published on: July 22, 2014

    Dear Ms. Foreman,

    Executive summary

    I wanted to follow-up on our telephone last meeting of June 16, 2014, with one of my clients who will remain unnamed in this public document. Let me first thank you for granting us that meeting which we took as a conference call not a face-to-face meeting. As you recall, we tried to explain our position on FDA's review of their 510(k) submission for which an NSE was issued on the grounds it allegedly raised different questions of safety and effectiveness.

  • 510(k)s/IDEs: The New Normal?

    • Authored by: Mark DuVal
    • Published on: January 1, 2012

    As many of you have encountered by now, FDA is not exactly shy when it comes to requesting clinical data for 510(k)s. Requests for clinical data are becoming the norm, rather than the exception. Today CDRH has a stag e-gating approach to the review of 510(k)s. They first review the file to determine if it meets the criteria for a 510(k), i.e. is there is a predicate, does the subject device have the same intended use and technological characteristics. If there are different technological characteristics, do they raise"new types" of questions of safety and effectiveness? If FDA review staff believe s you do not meet these 510(k) criteria, they send a letter stating that they have not reviewed the file substantively be cause FDA believes you do not (may not) qualify for the 510(k) pathway.

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