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.

  • Seven Quick Tips for 510(k) Submissions

    • Authored by: Mark DuVal
    • Published on: May 21, 2016

    We have had a lot of success over the years in filing 510(k) submissions on behalf of clients. We are writing to share seven quick tips for filing 510(k)s. It is a simple synthesis of our expertise and experience drafting and filing 510(k) submissions for our clients. We can prosecute your 510(k) in a turnkey fashion or simply be part of the support team. You can ask us to be out front, behind the scenes, or as an advisor - so the FDA knows we are involved.

    Given our experience, which is measured collectively in decades of work negotiating and collaborating with the FDA, we know how to navigate the FDA process and how to file 510(k)s that will get you through the system faster. If we do not draft the 510(k), we can help you plan your submission and provide your team with strategic direction regarding predicate choices, making definitional arguments, laying out the 510(k) in a compelling and persuasive fashion, and making sure you comply with the RTA and eCopy guidelines. We can also help you think through your interface with the FDA - from early dialogue in responding to Additional Information Letters, to interactive submissions, to Submission Issues Meetings, to a full-blown Pre-Sub.

  • FDA Often Sees No Data, Speaks No Data, Hears No Data

    • Authored by: Mark DuVal
    • Published on: May 21, 2016
    © DuVal && Associates
    Is FDA not reviewing your data in a 510(k) submission?
    Have you ever received a Not Substantially Equivalent (NSE) letter from FDA stating your device does not meet of the definitional elements of "substantial equivalence?"
    Did FDA do this without even looking at your data when your data may have helped your device meet the SE definition?

    Well, join the club - where FDA sees no data, speaks no data, hears no data.

  • Addressing Technological Characteristics In Your 510(k)

    • Authored by: Mark DuVal
    • Published on: March 20, 2016
    Finding the similarities between apples and oranges.

    One of the main tasks in your 510(k) submission is comparing the technological characteristics of your device to your chosen predicate device. Like the issue of whether a device has the same intended use, FDA is more restrictively interpreting when a device has the same technological characteristics. When that happens, the device becomes ineligible for the 510(k) path.

    Your assignment, should you choose to accept it, is to convince FDA of the "sameness" between your device and the predicate. You must persuade FDA that your device is like the predicate even when there are some differences. FDA must be convinced that those differences are not so great that the device is deemed to have technological characteristics that are different. "It's like comparing apple to oranges," the well-known idiom, implying the comparison is to things that are quite different; except the exercise here is to find the similarities between apples and oranges. This requires making more than a superficial comparison. It requires finding the essential nature of the technology and whether the individual technological characteristics accomplish the same therapeutic mission as the predicate, possibly in a slightly different way, or do they do more or something different such that it really is a different device. It often takes a mindset from the reviewer that is looking for technological similarities rather than the differences from the predicate...

  • Unbroken: The Howard Root/Vascular Solutions Acquittal

    • Authored by: Mark DuVal
    • Published on: March 2, 2016
    © Howard Root/Vascular Solutions

    This is a story of a CEO and a company in which the government brought a criminal case based upon the alleged off-label promotion of a 510(k) cleared medical device.

    Howard Root and Vascular Solutions settled a related whistleblower civil case without admission of liability by paying $520,000 to the federal government. Not satisfied with the civil settlement, the Department of Justice and U.S. Attorney's Office pursued the Mr. Root and the company on criminal charges of selling an adulterated and misbranded medical device and conspiracy to do the same. Howard's legal team vigorously defended by maintaining the use was onlabel and that even if it wasn't their client had the 1st Amendment right to provide truthful information about that use. The jury brought in a unanimous verdict acquitting both the CEO and company.

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