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- Authored by: Mark DuVal
- Published on: May 21, 2016
We have had a lot of success over the years in filing 510(k) submissions on behalf of clients. We are writing to share seven quick tips for filing 510(k)s. It is a simple synthesis of our expertise and experience drafting and filing 510(k) submissions for our clients. We can prosecute your 510(k) in a turnkey fashion or simply be part of the support team. You can ask us to be out front, behind the scenes, or as an advisor - so the FDA knows we are involved.
Given our experience, which is measured collectively in decades of work negotiating and collaborating with the FDA, we know how to navigate the FDA process and how to file 510(k)s that will get you through the system faster. If we do not draft the 510(k), we can help you plan your submission and provide your team with strategic direction regarding predicate choices, making definitional arguments, laying out the 510(k) in a compelling and persuasive fashion, and making sure you comply with the RTA and eCopy guidelines. We can also help you think through your interface with the FDA - from early dialogue in responding to Additional Information Letters, to interactive submissions, to Submission Issues Meetings, to a full-blown Pre-Sub.
© DuVal & Associates
- Authored by: Mark DuVal
- Published on: March 1, 2016
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.