Seven Quick Tips for 510(k) Submissions

Hitting the mark on your 510(k) submission

  • Authored by: Mark DuVal
  • Published on: May 21, 2016

Executive summary

This is the 2nd Client Alert in a series on 510(k)s: a continuing series of Client Alerts on drafting and filing strategies for 510(k)s. Here we provide tips to ensure your 510(k) is an advocacy document which will garner the clearance you seek.

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.

We frequently inherit 510(k)s that either were not drafted well or involve situations where the client was "stuck" in the 510(k) process with FDA. We know how to get you "unstuck." We are at FDA on average three times per month negotiating Pre-Sub meetings, 510(k)s, de novos, PMAs, and other matters on behalf of clients. We have earned the trust and respect of FDA and we advocate, when needed, for our clients so matters do not languish. We make sure FDA does not request inappropriate information or apply requirements irrelevant to a 510(k) determination. As much as FDA has improved in many areas, making timelines is not one of them and they can ask for information they want, not what they need or are entitled to, under the statutory and regulatory requirements of the 510(k) program. We will make sure - through our input, editing and advice - that your 510(k) is the advocacy document it needs to be. Our 510(k) team and their bios are listed below and we are ready to help you.

Seven Quick Tips for 510(k) Submissions

  1. Begin with the end in mind - what marketers need to make your product differentiable and what product developers need to know
    • Pick your predicates and intended use statements from your chosen predicate(s) wisely; be as close to the predicate(s) as possible - think "sameness".
    • Make sure the developers understand how any changes to materials, technological approaches, the mechanism of action or functionality can impact FDA's review - think "sameness slightly progressed".
    • Understand whether your technological characteristics raise different questions of safety and effectiveness - think "explainable sameness".
    • Understand FDA's legitimate role and concerns - conduct an opposition analysis to anticipate FDA's concerns and questions.
  2. Remember the 510(k) is an advocacy document, not just an evidentiary document
    • Start with a statutory/regulatory/guidance analysis: construct your argument from the beginning - use FDA guidance as necessary using FDA's own words against them.
    • Don't "sell" your 510(k) to the FDA arguing how it meets an unmet clinical need, how it is superior or will change the practice of medicine - promote your product after clearance.
    • Don't "sell" your 510(k) to the FDA arguing how it meets an unmet clinical need, how it is superior or will change the practice of medicine - promote your product after clearance.
    • There are many opportunities throughout the document to succeed or derail your submission.
    • Think big picture: how can I make this device fit into the existing 510(k) framework.
    • It suggests to the FDA you know you what you are talking about and will hold them to the framework too.
  3. Choose your predicates carefully and defend multiple predicates
    • FDA wants you to select a primary predicate - you are entitled to more.
    • FDA may suggest multiple predicates are inappropriate; split predicates are inappropriate.
    • Defend your choice using FDA's guidance documents.
  4. When considering intended use statements understand the predicate landscape well and consider any additions carefully
    • When writing your intended use statement think "sameness".
    • You can use an amalgam of predicates, but FDA likes a primary one.
    • FDA fights indication expansion: know how to advance this argument.
    • It is ironic that with a general intended use statement and without specifically stated indications, the device could be marketed for everything and yet nothing.
    • Understand FDA's guidance on "General/Specific Intended Use" ("levels of specificity" and "decision making" criteria) but do not be overly reliant on it, because FDA ignores it when it supports their position and uses it when it does.
    • It's easier to promote for use as a "tool" than ask FDA to allow you to focus in on one indication that FDA might consider a "treatment".
    • Consider the full commercialization strategy when submitting - some indications must come in subsequent submissions; also think about claims from a reimbursement perspective, e.g., how will the indication you are seeking impact reimbursement?
  5. Consider the impact of your technological characteristics - the more differences, the more explanation and substantiation.
    • Influence the device design to allow for profitable comparisons to the predicate - again, think "sameness".
    • Remember any substantial changes require explanation and/or data.
    • Show the technological progression in the predicate family and that yours is not an outlier - think "sameness slightly progressed".
    • Don't "sell" the superiority of your device to the Agency or that it meets an unmet clinical need or will change the practice of medicine.
  6. Anticipate and address the different questions of safety and effectiveness raised by your technological differences
    • Identify and address them, because FDA will - superficially; make arguments that they are not "different" questions - think "explainable sameness".
    • Use FDA's own Additional Information (AI) questions and guidance documents against them.
    • Don't forget to use "reference" devices to demonstrate FDA has seen this technology/questions before.
    • Provide data where needed to assure FDA you have been thorough.
    • Consider data needs carefully and whether you will need FDA's input in advance (i.e. PreSub).
  7. Attend to the basics
    • Refusal-to-Accept Policy
    • eCopy Policy
    • Deadlines and communication
    • Avoiding Pre-Subs (Q-Subs) where possible, but managing them correctly when needed.
The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM