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...

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What are you creating Dr. Frankenstein?

"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...

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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,”

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Beware that FDA frequently interprets the definition of “general versus specific intended use” so narrowly that FDA often considers new indications for a 510(k) device to be a new intended use. This is in contravention of the specific intent of the Congress. 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.

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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.

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