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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)?

    • Authored by: Mark DuVal
    • Published on: October 31, 2017
    © 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?

    • Authored by: Mark DuVal
    • Published on: September 20, 2017
    "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...

  • Choosing the Proper Predicate Device(s)

    • Authored by: Mark DuVal
    • Published on: May 10, 2017

    One of the key choices for staying on the premarket notification ("510(k)") pathway is choosing the right predicate device(s). In 2011, FDA conducted a review of its "Not Substantially Equivalent" ("NSE") determinations from 2005-2010 and found that lack of a "suitable predicate" was one of the top four reasons for NSE determinations.1 As you know, a 510(k) needs to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device ("predicate device"). To be declared "substantially equivalent," the new device must have (1) the same intended use as the predicate device, and (2) the same technological characteristics as the predicate device or (b) have different technological characteristics but show that the differences do not raise different questions of safety and effectiveness from the predicate device. Choosing the right predicate device is one of the (if not the) most important components in a 510(k) strategy; choosing incorrectly can mean that more time, effort and resources are needed to clear your device, and moreover, it can put your clearance at risk. And sponsors need to know upfront that FDA does not always agree with a chosen predicate or may suggest that the sponsor must have only one predicate and is not entitled to multiple predicates. Additionally, the review staff may or may not understand or embrace the appropriate role for "reference devices." We explain these to you in this Client Alert.

  • 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.

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