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.

  • Medical Devices And 510k Modifications

    • Authored by: Mark DuVal
    • Published on: February 1, 2017

    Transformers® start out as a car or truck, but with a few gyrations they morph into a fighting machine capable of attacking or defending enemies. Surely, they do not look anything like they did before, but has their essential character changed, has their intended use? Do the changes significantly affect their safety or effectiveness? They always had the same purpose, and arguably the same technological characteristics.

    Is Superman® any different than the seemingly mild-mannered Clark Kent disguised as a reporter? He changes in a phone booth or closet and comes out Superman. He is always the same Superman just packaged differently. He has the same strengths—fast as a powerful locomotive, able to leap tall buildings in a single bound, weakened by Kryptonite. How do we define change? For medical devices, change is constant, expected and essential to the continuous improvement of medical devices. But wholesale and unnecessary change to the statutory and regulatory scheme governing when that change is immediately reportable to FDA, and requires FDA clearance in the form of a new 510(k), is not. It is even more problematic when that interpretative change is instigated by an Agency that would like to grab more authority and jurisdiction through its self-created guidance documents. In this Client Alert, we explore the pros and cons of FDA's draft guidance on modifications to 510(k)s now that it has been out in draft form for some time.

  • 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.

  • Clearing Your Indications for Use

    • Authored by: Mark DuVal
    • Published on: March 1, 2016
    © DuVal & Associates
    Staying Under the Umbrella of Intended Use

    When making a 510(k) submission, the FDA will often "play" with the definitions to define a sponsor’s subject device in a manner that takes it off the 510(k) path. That is why it is critical for the sponsor to thoroughly understand the 510(k) substantial equivalence definition criterion, as well as FDA’s guidance documents so the sponsor can make arguments that ensure each definitional criterion is met. Otherwise the subject device is headed for the de novo or PMA path, and more time and expense.

    The very first definitional criterion that must be satisfied is whether the subject device has the same "intended use" as the predicate device. FDA today often takes advantage of this seminal criterion to issue a Not Substantially Equivalent (NSE) determination, concluding that the subject device does not have the same intended use as the predicate device. FDA will often conclude that specific indications do not fall under the general intended use statement or that the general intended use statement is simply broader or different from the predicate. This is done despite the fact that FDA’s guidance documents do a fair job of setting forth the flexibility with which the 510(k) program is to be interpreted, i.e. to allow for variations in labeling to allow for broader application of the device. The problem is that without specific indications, a device with a general intended use statement is seemingly cleared for everything (relatively speaking), but can be used for nothing.

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