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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.
- Authored by: Mark DuVal
- Published on: March 20, 2016
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...
© Howard Root/Vascular Solutions
- Authored by: Mark DuVal
- Published on: March 2, 2016
This is a story of a CEO and a company in which the government brought a criminal case based upon the alleged off-label promotion of a 510(k) cleared medical device.
Howard Root and Vascular Solutions settled a related whistleblower civil case without admission of liability by paying $520,000 to the federal government. Not satisfied with the civil settlement, the Department of Justice and U.S. Attorney's Office pursued the Mr. Root and the company on criminal charges of selling an adulterated and misbranded medical device and conspiracy to do the same. Howard's legal team vigorously defended by maintaining the use was onlabel and that even if it wasn't their client had the 1st Amendment right to provide truthful information about that use. The jury brought in a unanimous verdict acquitting both the CEO and company.
© 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.
- Authored by: Mark DuVal
- Published on: October 5, 2015
Do you remember the story of Mighty Casey (FDA) at bat, let us rewrite the story a bit to fit our story/analysis:
The outlook wasn't brilliant for Mudville (HHS) that day; the government team had never lost, always having it their way. Suppressing speech and pushing industry around; never mind the Constitution, their arrogance would abound. After his predecessors swung blindly at WLF and whiffed at Caronia, the Mighty Casey raised his hand to the government crowd, "Don't worry my friends, when I'm done, industry will be downed."
But the little guy Amarin stepped up to the mound, knowing the previous industry pitchers (WLF and Caronia) had kept the ball on the ground - for outs. This was the kind of day that made the Mighty Casey shout. Said Casey: