Preparing for FDA submissions isn’t new to us. As project management consultants for the medical device industry, prepping for these(among other project management activities) is what we do well. Currently, one of our clients is in the middle of an FDA submission, responding to a round of questions. The lessons from this, and from many other submission prep efforts, are very top of mind right now, so I thought I’d share them with you.
- The dos of preparing for FDA submissions in the medical device industry
- The don’ts of preparing for FDA submissions in the medical device industry
- Words of wisdom from many FDA submissions
- The only way to avoid misses when preparing for FDA submissions is organization
- Think Like the FDA
- FAQs about FDA submission preparation
The dos of preparing for FDA submissions in the medical device industry
1. Understand your Project Manager’s role in the process
Project managers (PMs) are not usually regulatory experts. We may be very experienced at shepherding projects through the FDA process, but we shouldn’t be relied on for knowing every single regulatory nuance. That’s your regulatory expert’s job.
Our job is to make sure the entire submission is coordinated, organized, and executed on time—without missing a single critical detail.
2. Create an FDA submission checklist and plan for medical devices
There needs to be a plan dedicated entirely to the plethora of documents the FDA requires. This isn’t something you want to “figure out along the way.” Your regulatory expert, your team, and you need to define a very strict checklist of all the documents that the FDA needs.
Your FDA submission plan should include:
- Your regulatory expert’s input and experience – They know what the FDA wants to see (and what they’ll push back on).
- Your team roster – Identify every person involved in preparing, reviewing, and approving documents. Make sure roles and responsibilities are clearly defined.
- A strict checklist of required documents – The more complete and specific this list is, the better off you’ll be when it’s time to hit that “Submit” button.
- A version control and review process – Ensure there’s a system for tracking revisions and approvals so outdated files never make it into the final package.
A well-built submission plan helps you anticipate workload, spot gaps early, and keep all stakeholders aligned from day one.
3. Assign responsibility for every document.
Once you have your checklist, assign one person to be responsible for each document. Some documents will be required earlier in the project—those should already be in the Design History File and can be set aside for now. But for everything else, accountability matters. Every document should have a single accountable owner, even if multiple contributors are involved.
4. Anticipate FDA questions early.
The medical device project manager and regulatory manager should take a step back and ask:
“If I were the FDA, what would I question here?”
This is essentially a risk analysis—but not of your device itself. Rather, it’s a risk analysis of your submission.
For each of the technical items in your submission(or in your responses to FDA questions), conduct a risk analysis focused on what the FDA is likely to scrutinize. You can bring in another regulatory team member to play the role of the FDA reviewer. Where are they going to be fussy? Persistently obnoxious?
Your regulatory expert should also be familiar with the FDA’s current “hot points”. For example, cybersecurity is a big focus area right now. If a medical device is susceptible to cybersecurity risks, the FDA can ask questions like:
- How are you protecting patients and users from hackers?
- If someone does get in, how limited is the amount of data they can access?
- How quickly can you detect a breach?
If you’re working with new technology, be prepared to show the FDA that it’s safe. Or at least that the benefits outweigh the risks.
If you do this exercise early enough, you can work with your engineering staff to address these concerns proactively, so that by the time the FDA reviews your submission, the answers they’re looking for are already built in.
5. Integrate the FDA submission into your project schedule
Now that you have your FDA submission preparation guide, your risk review, and document owners, integrate the submission effort into your overall project schedule.
Having a dedicated timeline for the submission keeps it visible to both the project team and any management oversight. It also ensures no one treats it as an “extra task” outside of the main workflow.
The don’ts of preparing for FDA submissions in the medical device industry
6. Overlook labeling
In my experience, the FDA is always very concerned about labeling. Have multiple reviews of your labeling to catch potential issues before submission. Small details can cause big delays if they’re not caught early.
7. Rely on ad-hoc planning when preparing for FDA submissions
One of the fastest ways to derail an FDA submission is to treat it like just another project deliverable you can pull together at the end. Without a dedicated, detailed plan, you risk:
- Missing critical documents – The FDA won’t approve an incomplete submission, and finding out you’ve overlooked something late in the process can delay clearance or approval by months.
- Last-minute scrambling – Without assigned ownership, documents often get stuck in limbo between contributors, leading to bottlenecks when deadlines are already tight.
- Inconsistent information – When testing results, labeling, and risk documentation aren’t aligned, the FDA will notice—and they’ll ask questions you’re not ready to answer.
- Inefficient use of resources – Pulling people off other work to address gaps at the last minute disrupts schedules and increases the chance of errors.
- Higher stress and greater potential for mistakes – Rushed work, unclear responsibilities, and poor version control make it far more likely that incorrect or outdated information will slip through.
Words of wisdom from many FDA submissions
The medical device FDA approval process always takes longer than you think. Build in extra time for reviews, clarifications, and inevitable questions.
Coordination(or lack of it) between different areas of expertise within your technology becomes very clear when someone reviews the entire submission to ensure everything works together. Doing this well in advance of the actual FDA submission will uncover inconsistencies in your development—issues that would otherwise only surface at the very end, when they’re much harder to fix.
Even with planning, there will be some surprises. Your job is to minimise the surprises.
The only way to avoid misses when preparing for FDA submissions is organization
The best way to avoid mistakes is to be as organized as possible. Have specific people responsible for specific items by specific deadlines. That’s Project Management 101—with the added twist of having to think like an FDA approver.
Think Like the FDA
The best mindset I bring to this process is:
“What are they going to ask and why?”
The FDA doesn’t wake up every morning hoping to reject submissions. Their main goal is to ensure that the products they review are safe enough for use.
If you put yourself in their place, you can anticipate their questions and address them before they’re even asked. The desired outcome is always the same: a successful submission and faster time to market.
If you want your FDA submission process to run smoothly, involve a project manager who understands medical device development from the start. We know how to keep the moving parts aligned, anticipate challenges, and make sure you’re not scrambling at the eleventh hour.
Because in this game, preparedness isn’t optional—it’s everything.
Want a dedicated project manager who can do all the above and more?
FAQs about FDA submission preparation
The required documents vary depending on your device type and submission pathway (510(k), PMA, De Novo, etc.), but typically include testing reports, risk management files, labeling, design history files, and clinical or non-clinical data. Creating a strict checklist early ensures nothing critical is missed.
A project manager coordinates the entire submission process — assigning document ownership, maintaining version control, integrating the submission into the project schedule, and keeping the team aligned. While they are not regulatory experts, they ensure everything is organized, complete, and on time.
Conduct a submission-focused risk analysis. Ask, “If I were the FDA, what would I question here?” Have team members review documents as though they were FDA reviewers, and stay updated on current “hot points” like cybersecurity. This helps address concerns proactively before they delay approval.
Labeling is often scrutinized by the FDA. Inconsistent or unclear labeling can cause major delays. Multiple reviews of labeling are recommended to ensure accuracy, clarity, and compliance before submission.
It typically takes longer than expected. Building in extra time for reviews, clarifications, and responding to questions is essential. A dedicated submission plan integrated into your overall project schedule helps prevent last-minute scrambling and delays.
Treating submissions as ad-hoc deliverables instead of dedicated projects.
Missing critical documents due to poor planning.
Failing to assign clear document ownership.
Overlooking labeling details.
Allowing inconsistent information across testing, risk, and labeling documents.
Start early, involve both regulatory experts and project managers, assign clear responsibilities, and anticipate FDA concerns. The key is strong organization, proactive planning, and thinking like an FDA reviewer.