Preparing your first 510(k) submission? You’re not alone if it feels overwhelming.
Between evolving regulatory requirements, nuanced guidance documents, and high expectations from FDA reviewers, it’s easy for early-stage MedTech teams to get lost in the process. Especially for startups or small teams, navigating these waters without the right insights can lead to missteps, delays, and costly rework.
That’s why we went straight to the source. At QuickVault by Veeva, we work closely with expert regulatory consultants who help MedTech companies bring innovative devices to market. We asked a few of our most trusted partners to share their top insights for companies tackling their first 510(k), and paired their advice with additional context to help your team avoid common pitfalls.
What’s the most common mistake you see companies make with their first 510(k)?
First-time 510(k) submitters often misjudge just how rigorous the FDA’s expectations are. Choosing a predicate device that’s not a close match, providing incomplete or misaligned performance data, and neglecting critical guidance documents are all frequent mistakes that lead to costly delays, or worse, outright rejection.
According to FDA reviewers, even small gaps in documentation can trigger Refuse to Accept (RTA) decisions. And as our panel of experts confirmed, these missteps are preventable with the right planning.
Here’s what the experts had to say:
Edwin Lindsay, Compliance Solutions:
“Choosing an inappropriate predicate device, inadequate comparison, missing or incomplete performance data, and overlooking guidance documents.”
Helene Quie, Qmed Consulting:
“Companies do not engage with the FDA early enough… If the FDA is approached, there is often a lack of knowledge of the existing guidance and how to implement it.”
Karandeep Singh Badwal, QRA Medical:
“Missing/incomplete documentation.”
Carolyn Guthrie, Helix Medical:
“Underestimating the objective evidence (test data) required to demonstrate substantial equivalence.”
Michael Chen, Rook Quality Systems:
“Not fully documenting the justification/evidence on how the device is as safe/effective, even when it’s obvious to those familiar with the tech.”
Dr. Nisha Vempalle & Adarsh Anand, RegTrac:
“The most common mistake is underestimating the level of detail and documentation required…especially predicate comparison and performance testing sections.”
Key Insight: Thorough documentation, including the data demonstrating device safety and effectiveness, is not a formality, it’s the backbone of your submission. Teams that rush to submit without understanding FDA expectations often face costly rework.
What's one piece of advice for MedTech startups preparing their first submission?
Every expert we interviewed emphasized the same idea: start early, and engage FDA proactively.
The Q-Submission (Q-Sub) process, particularly the Pre-Sub, is a low-cost, high-impact approach to validate your regulatory strategy before investing in device testing. It’s an opportunity to get FDA’s feedback on critical elements like your predicate selection, testing strategy, and labeling claims.
Just as important is involving experienced regulatory professionals early in product development. From aligning risk management with ISO 14971 to building your labeling with GUDID requirements in mind, early regulatory input sets the stage for success.
Edwin Lindsay:
“Engage with the FDA early and often, especially through the Pre-Submission (Q-Sub) process.”
Helene Quie:
“Use modular reviews and Pre-Submissions… Break up the work into modules: technical file prep, labeling, and substantial equivalence rationale.”
Karandeep Singh Badwal:
“Always get an expert who has past experience to review your documentation before submitting.”
Carolyn Guthrie:
“Use the Q-submission process, but use it at the right time.”
Michael Chen:
“Providing test reports isn’t enough. Demonstrate equivalence explicitly, via method or data.”
Dr. Nisha Vempalle & Adarsh Anand:
“Start regulatory strategy from Day 1. Don’t treat submission as a formality.”
Key Insight: Don’t wait until you’re ‘submission-ready’ to think about your regulatory strategy. Early, strong Pre-Sub engagement with the FDA and early expert guidance are critical success factors.
What part of the 510(k) process tends to catch teams off guard?
Even well-prepared teams can be surprised by how nuanced and granular the 510(k) process can be.
For example, many teams don’t anticipate the level of evidence needed to prove substantial equivalence, especially if their predicate device differs slightly in design or materials. Others are surprised by how long certain testing efforts take, or how many parallel workstreams are required to avoid bottlenecks.
And then there’s the interactive review phase. While your 510(k) may be accepted initially, the Additional Information (AI) requests can be extensive, and time-sensitive.
Edwin Lindsay:
“First-time submitters underestimate the amount and type of testing required, bench, biocompatibility, electrical safety, software validation, and sometimes clinical data.”
Helene Quie:
“Teams often wait too long to begin regulatory preparation. Testing, predicate comparisons, and labeling should start while development is still ongoing.”
Karandeep Singh Badwal:
“Understanding and justifying substantial equivalence, especially with nuanced predicate differences, often trips teams up.”
Carolyn Guthrie:
“FDA guidance documents are not legally binding, but reviewers expect you to align with them.”
Dr. Nisha Vempalle & Adarsh Anand:
“Most teams are unprepared for the Additional Information (AI) phase. Labeling and UDI are often afterthoughts but can cause major delays.”
Key Insight: You’ll need to plan ahead not just for your initial submission, but for the back-and-forth that follows. Ensure you have enough buffer time to allow for unexpected questions and delays. A 510(k) submission and associated clearance is a process, not a milestone.
How do you recommend companies balance speed and quality when getting to submission?
Speed and quality are often seen as trade-offs, but they don’t have to be.
According to our experts, the fastest path to market is actually the one paved with upfront planning. Investing time to define regulatory strategy, parallelize workstreams, and anticipate FDA requirements leads to fewer delays and less rework.
This also means resisting the urge to “gold-plate” everything. As Helene Quie puts it: focus on being fit-for-purpose, not perfect.
Edwin Lindsay:
“Start with a clear strategy, invest upfront in planning, and use the FDA Pre-Sub process. Parallelize workstreams and prep for post-submission interactions.”
Helene Quie:
“The balance! Aim for fit-for-purpose quality, thorough, but not gold-plated.”
Karandeep Singh Badwal:
“Build quality in from Day One. It reduces rework.”
Carolyn Guthrie:
“Use seasoned professionals. It’s faster in the long run.”
Michael Chen:
“Use testing wait time to prep and review other submission sections.”
Dr. Nisha Vempalle & Adarsh Anand:
“Start slow to go fast. A well-planned 510(k) that invests time upfront will move more smoothly through review.”
Key Insight: Speed and quality aren’t opposites. Rushing leads to rework. Plan early, and you’ll move faster, and smarter.
Key Takeaways
- Start early: Initiate regulatory planning during product development, not after. Many companies wait too long to involve regulatory, which can lead to misalignment between product design and FDA expectations.
- Engage FDA: Use the Q-Sub process to validate your approach and avoid missteps. It’s a low-cost, high-return strategy to de-risk your submission before investing time and resources into full testing.
- Document everything: From predicate comparisons to labeling, leave no gap. The FDA expects detailed, structured documentation that follows guidance documents and formatting requirements, don’t assume anything is implied.
- Plan for the interactive review: Be ready to respond quickly to Additional Information (AI) requests post-submission. Build margin into your timeline and ensure your team can rapidly produce supplementary data.
- Build quality from day one: Don’t treat compliance as an afterthought. Integrating standards like ISO 14971 and CFR 820 early into your development process will help you avoid downstream remediation and delays.
- Lean on experts: External consultants can help you identify blind spots, validate strategies, and fast-track your path to clearance. Their experience with similar products or FDA reviewers is often invaluable.
No two 510(k)s are identical, but success tends to follow the same path: thoughtful planning, strategic engagement, expert input, and meticulous documentation.
Get Submission-Ready with QuickVault
QuickVault by Veeva was built for MedTech teams preparing their first (or fiftieth) submission. Our platform helps you manage documentation, testing data, labeling, and design history files in one secure, audit-ready workspace.
Our new submission functionality was designed with FDA expectations in mind, from predicate comparisons to labeling readiness.
Book a personalized demo today to see how QuickVault can help you get to market faster.
Meet the Experts
Edwin Lindsay
Principal Consultant & Managing Director, Compliance Solutions
LinkedIn • Website
Helene Quie
CEO, Qmed Consulting
LinkedIn • Website
Karandeep Singh Badwal
Founder & Lead Consultant, QRA Medical
LinkedIn • YouTube
Carolyn Guthrie
Founder, Regulatory & Quality, Helix Medical
LinkedIn • Website
Michael Chen
Senior Quality Engineer, Rook Quality Systems
LinkedIn • Website
Dr. Nisha Vempalle
Vice President, Global Regulatory Affairs, RegTrac
LinkedIn • Website
Adarsh Anand
Team Lead, Regulatory Affairs, RegTrac
LinkedIn • Website
