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.

  • What Is The Quantum And Quality of Information Needed For Your 510(k)?

    • Published on October 31, 2017
    • Authored by Mark DuVal
    © 1974 - Twentieth Century Fox Film Corporation
    "My creation: It's pronounced ‘Fronkensteen'!"
    What are you creating Dr. Frankenstein?

    When Dr. Frankenstein undertook the creation of his subject it was a well-intentioned misadventure. His attempt to create something beautiful and extraordinary ended up being something hideous and unmanageable which sought to kill others. Dr. Frankenstein had made something reprehensible and dangerous to mankind.

    While FDA's attempts to create a package of data that will protect the American public is laudable and well-intentioned, their involvement often results in data requests involving over-sized parts and pieces, unnecessary to the creation of the being (dataset) to ensure it is safe and functionally works. FDA's requirements are substantially delaying and many times killing innovations beneficial to patients. No matter what the quality and quantity of the data submitted by a 510(k), many reviewers seem to believe it is never correct, sufficient, or adequate...

  • When Does Your Device Raise Different Questions Of Safety And Effectiveness?

    • Published on September 20, 2017
    • Authored by Mark DuVal
    "It's elementary, my dear Watson."

    When Sherlock Holmes uttered those famous words to his assistant and sidekick, Dr. Watson, it underscored how he had unlocked the mystery of an intractable case and was ready to share it with him. But Sherlock's skills were applied to cases of first impression and difficult, murky facts. He unlocked those mysteries through inductive and deductive reasoning. He made difficult things elementary.

    FDA often does just the opposite. It makes simple things difficult.

    We don't need a Sherlock Holmes in FDA's interpretation of the 510(k) program. It was designed to be the plow horse of the American medical device pre-market system because it operates on what is already known and knowable, i.e. precedent. It may not be sexy, or fast, high science, like the PMA program, but it has served the American public well. FDA, possibly out of boredom or a desire to grow its regulatory fiefdom, has made the 510(k) program something it was not intended it to be - high science and making the known, mysterious. FDA frequently contorts its definitional and scientific analysis to find a device somehow has different technological characteristics and raises new questions of safety and effectiveness. FDA often uses this analysis to bounce a device off the 510(k) path and on to either the de novo or PMA path...

  • Addressing Technological Characteristics In Your 510(k)

    • Published on April 16, 2017
    • Authored by Mark DuVal
    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...

  • Clearing Your Indications for Use

    • Published on March 1, 2016
    • Authored by Mark DuVal
    © 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