What a Strong 510(k) Submission Looks Like in 2026
We’ve been seeing an uptick in 510(k) inquiries support inquiries. Here are a few best practices we abide by.
Over the past few months, we’ve seen a notable increase in requests for 510(k) support. Some are first‑time submitters. Others are experienced teams who’ve cleared devices before—but are finding that what worked even two or three years ago is no longer producing smooth, predictable reviews.
That trend isn’t all that surprising. Review expectations continue to evolve. Device complexity (software, connectivity, AI‑adjacent functionality) keeps increasing. And FDA reviewers are under the same pressure everyone else is—limited time, growing submission volume, and an expectation to identify real risk faster.
So we wanted to step back and document what we’re seeing work consistently. Not theoretical best practices—but patterns that show up again and again in submissions that move efficiently through review, versus those that stall, reset, or spiral into multiple rounds of questions.
We polled some of our busiest regulatory consultants to give you the most impactful insights mature teams use, but most firms overlook. If you want help strengthening your own submission strategy (or getting a wobbly one back on track), talk to us!
Below are the core principles we’re advising device teams to adopt if they want a smoother 510(k) experience this year.
If premarket notifications are part of your life and you haven’t seen our discussion with one of our top 510(k) experts, Trey Thorsen, MS, RAC, be sure to give it a watch below.
1. Predicate selection is regulatory engineering, not a checkbox
One of the most common root causes of 510(k) trouble is underestimating predicate strategy.
Too many submissions still treat predicate selection as a one‑time decision made late in development. In reality, strong teams treat it as regulatory engineering: an early, deliberate exercise that shapes everything downstream—risk analysis, testing strategy, labeling, and ultimately the substantial equivalence argument itself.
What we see working:
Surveying the full predicate landscape early, not just the most obvious device.
Stress‑testing multiple candidates against intended use, technological characteristics, and known reviewer sensitivities.
Explicitly documenting why alternative predicates were rejected—not just why the chosen one fits.
Using reference devices strategically to contextualize specific features or technologies.
When predicate logic is weak, FDA questions tend to multiply. When it’s strong, reviewers often move quickly because the regulatory logic already makes sense.
2. Use the Pre‑Sub to lock expectations, not to “have a meeting”
The FDA’s Pre‑Submission program remains one of the most powerful tools available to device sponsors—but only when used with intent. We often say internally: a good Pre‑Sub reads like the opening chapter of the 510(k).
High‑value Pre‑Subs don’t ask FDA to design the submission for you. They present:
A clear intended use statement.
A defensible predicate strategy.
Identified technological differences.
A proposed test plan tied directly to those differences.
And then they the ask FDA to react to that.
Low‑value Pre‑Subs tend to ask broad, open‑ended questions (“Do you see any issues?”). Those almost always invite new concerns, additional data requests, or ambiguity that resurfaces during review.
In 2026, the teams seeing the most benefit from Pre‑Subs are the ones using them to lock the narrative and narrow uncertainty early.
3. Substantial Equivalence must read like a story
One recurring misconception we still see: that substantial equivalence can be proven with a table of differences plus a stack of test reports. In practice, reviewers need a story they can follow (especially when they’re reading your submission cold, with limited background on your device category).
Strong SE rationales explicitly walk through each technological difference. They explain what question of safety or effectiveness that difference raises. They describe how the selected evidence directly addresses that question, and then close the loop by stating why residual risk is comparable to the predicate.
Weak SE sections force the reviewer to connect the dots themselves. That almost always leads to clarification questions, additional information requests, or re‑framing of the review late in the cycle. Invest the time upfront so you don’t have to spend even more time later.
4. Treat RTA as an information architecture blueprint
The Refuse to Accept (RTA) checklist is often treated as a gatekeeper, a hurdle to clear after the submission is assembled. But high‑performing teams treat it as an information architecture blueprint from the start. That means:
Structuring the submission so required elements appear exactly where reviewers expect them.
Providing cross‑references when content is complex or shared across sections.
Making sure high‑risk domains (software, usability, cybersecurity) are easy to locate and navigate.
Avoiding critical content buried deep in appendices without context.
When reviewers can quickly find what they need, they spend more time assessing risk and less time asking where things are. This is one of the easiest ways to not get in your own way.
5. Build a learning loop across submissions
One of the clearest “maturity signals” we see is whether a company treats each 510(k) as a one‑off or as part of a continuous program. Teams that improve fastest track reviewer questions across submissions, identify patterns in what triggers follow‑ups, and then feed those lessons back into design, testing, and documentation templates.
Teams that institutionalize learning consistently see shorter review cycles and fewer surprises over time.
6. Don’t overlook transactional and operational compliance traps
Not all 510(k) risk lives in the technical sections! We’re increasingly advising clients on issues that sit at the fuzzy intersection of regulatory, legal, and operational execution—especially around acquisitions, transfers, and post‑clearance changes.
A few common pitfalls include:
Misunderstanding that only one entity can hold a 510(k) at a time.
Triggering the need for a new 510(k) through post‑transaction changes.
Missing registration and listing timing requirements.
Creating temporary misbranding exposure during transitions.
These issues rarely surface until something goes wrong. But when they do, they can derail otherwise solid regulatory programs.
7. Get the mechanics right so you don’t lose time unnecessarily
It sounds basic, but we still see avoidable delays caused by submission mechanics like incorrect or incomplete eCopy or eSTAR packages, missing files, broken links, or formatting issues, and inconsistent naming conventions that slow review.
Again, take the time to get out of your own way as much as possible—as early as possible. In a competitive environment, losing weeks to preventable administrative issues is costly, and entirely avoidable with the right internal checks (or external checks if you’re working with us).
8. Understand what FDA expects but doesn’t require in the submission
Finally, there’s value in clarity around expectations. For example, FDA generally does not expect you to submit full Quality System documentation within a 510(k). But reviewers absolutely expect that design controls, supplier controls, and other foundational systems exist and are functioning.
Strong teams plan accordingly—ensuring operational readiness aligns with the claims and evidence presented in the submission.
Why this matters in 2026
The bar for 510(k) success isn’t just technical compliance anymore. It’s clarity, coherence, and execution across regulatory strategy, documentation, and operations.
As inquiries continue to increase, we’re seeing the same pattern repeat: teams that treat the 510(k) as a strategic, engineered program move faster (and with far less friction) than those treating it as a filing exercise.
If you’re preparing a 510(k) this year, now is the time to step back and assess whether your approach reflects how the FDA actually reviews devices today.
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