Every FDA submission is a high-stakes project. Whether you're preparing a 510(k), De Novo, or PMA, the effort required to get to the finish line is significant — and missteps can cost you precious time, money, and momentum.
Too often, regulatory teams dive into documentation before they've stepped back and asked the right strategic questions. That’s why we’ve created this list: to help you assess your readiness, avoid common bottlenecks, and surface smarter paths forward — before you’re too deep in the weeds.
Here are 10 questions every regulatory team should ask before starting their next submission.
1. What’s the most appropriate regulatory pathway for this device?
Choosing the wrong pathway — or assuming the same one used previously — can cause serious delays. Each path (510(k), De Novo, PMA) has its own standards, timelines, and data requirements. Make sure you're matching your innovation to the right regulatory route from the start.
2. What predicate device(s) can we reference — and how strong is the equivalence?
In 510(k) submissions, predicate choice is everything. A weak match can trigger a cascade of review issues or lead to a Not Substantially Equivalent (NSE) decision. Do you have access to a robust list of relevant, recent predicates? Have you reviewed their summaries, risk classifications, and intended uses?
3. How did similar devices structure their submissions — and what can we learn from them?
Looking at successful submissions in your device class gives you valuable insight into how to frame your own. What claims did they make? What testing protocols did they follow? This kind of precedent benchmarking can inform your own strategy and reduce the number of review cycles.
4. Are we planning regulatory activities early enough in the product lifecycle?
Regulatory strategy shouldn't come after engineering is finished. If you're looping in your RA team post-design, you're already late. The best-performing teams integrate regulatory planning into early-stage product development.
5. Do we understand the key risk factors and mitigations for this device class?
Anticipate the questions your reviewers will ask. By reviewing similar devices, known issues, and prior refusals, you can proactively address risks before they're flagged by the FDA.
6. Are we reusing past research or starting from scratch?
Institutional knowledge loss is real — especially in fast-moving or high-turnover teams. If you're duplicating past efforts to identify predicates or write justifications, you're wasting valuable time. Smart tools can help preserve and build on your team’s prior work.
7. How long does this type of submission typically take — and how can we shorten it?
Timelines matter. By looking at historical FDA decisions, you can estimate a realistic review timeline and identify opportunities to reduce it — such as stronger predicates or more complete first-round packages.
8. Who are the FDA reviewers or branches that handled similar devices?
While not always visible, understanding which FDA branches or divisions have handled similar submissions can help you anticipate the kinds of questions or documentation standards you’ll face.
9. Are we tracking every assumption back to a source?
Every claim in your submission — about safety, effectiveness, equivalence — needs to be supported by data, references, or precedent. A traceable, auditable trail isn’t just good practice; it’s regulatory resilience.
10. Do we have the right tools to find, reference, and cite prior decisions quickly?
This may be the most important question of all. If your team is still manually searching FDA databases or stitching together information from PDFs, you're not just wasting time — you're increasing the risk of oversight. Investing in smarter workflows can save hundreds of hours and significantly strengthen your submission.
Final Checklist: Are You Ready to Submit?
Before you move forward, make sure you’ve:
💡 Strategic Submissions Start with Strategic Questions
Too often, regulatory submissions are treated like paperwork. But the smartest MedTech teams know that regulatory is strategy. A well-informed, precedent-based approach can mean the difference between a smooth path to market — and months of costly back-and-forth.
Agent Astro was built to help regulatory teams answer these questions faster — and with confidence. From predicate research to precedent identification, we streamline what matters most.
