Articles by Michael Drues

  1. 510(k) Substantial Equivalence In Plain English — Part 2

    Part 1 of this article sought to provide a better understanding of the concept of substantial equivalence in premarket notifications, more commonly known as 510(k)’s, using easy-to-understand metaphors. We also looked at recently issued CDRH draft guidance concerning different technological characteristics of a 510(k) submission. In Part 2, we move on to another piece of recent CDRH guidance, this one dealing with the controversial topic of split predicates.

  2. 510(k) Substantial Equivalence In Plain English — Part 1

    The two most important components of a successful 510(k) submission are the substantial equivalence argument and the risk mitigation strategy. This two-part article will focus specifically on the substantial equivalence component, explaining what it is and how to establish it. It will also explore two recently issued FDA guidances related to substantial equivalence, and how they should influence your regulatory strategy.

  3. Is Your Boring Regulatory Strategy Costing You Business?

    When people in the medical device world use the phrase “regulatory strategy,” they usually mean the path they will take to get their product onto the market. And when they say “competitive regulatory strategy,” they are usually referring to the way their competitor(s) got their products onto the market.

  4. Take Control Of Your Medical Device’s FDA Classification

    If you’re developing a medical device that’s substantially equivalent to an existing device, then the FDA classification process can seem straightforward. Simply head over to the classification database on the CDRH website, enter the relevant information about your product, hit the search button, and viola! You can quickly determine whether your device fits into the Class I, II, or III category. At least, that’s what most people think.  Reality, however, is far more complicated, and there are exceptions to every rule. The best regulatory strategies take advantage of the exceptions – not just the rules.

  5. FDA’s PMA Pathway: Friend Or Foe?

    Approximately 10% of all medical devices enter the U.S. market through the FDA’s premarket approval (PMA) process, making it the second most-used U.S. pathway behind the 510(k). Since the PMA path is required for devices that are high risk (Class III) or for which no predicate exist, it is much more rigorous — that is to say, more complex and time consuming — than the 510(k).

  6. Combination Products 101: A Primer For Medical Device Makers

    The current definition of a combination product, according to the Code of Federal Regulations (CFR), is a product that involves a medical device and/or a drug and/or a biologic —combining any two of these product classes, and sometimes even all three.

  7. Secrets Of The De Novo Pathway, Part 2: Is De Novo Right For Your Device?

    In Part 1 of this series, we explored the history of the FDA’s de novo classification — what it is, why it was established, why it has been underutilized by medical device makers, and what the agency has done in recent years to make it a more attractive option. But is it the appropriate pathway to market for your novel low-risk device? This second installment seeks to help you answer that question by contemplating several key regulatory and business considerations related to the de novo process.

  8. Secrets Of The De Novo Pathway, Part 1: Why Aren’t More Device Makers Using It?

    The de novo classification option, introduced as part of the U.S. Food and Drug Administration Modernization Act of 1997 (FDAMA), was developed as a new regulatory pathway for novel low-risk medical devices. Interestingly, this alternative to the lengthy premarket approval process (PMA) has never quite caught on among device makers. In fact, it remains one of the least-traveled routes to market for new devices.