A strong pre-submission is a strategic tool. When reviewers are stretched thin, submission quality shapes the experience.
By Acacia Parks, Lindus Health
Acacia Parks is an advisor to Lindus Health and the founder of Liquid Amber. [Photo courtesy of Liquid Amber]
Staff reductions have limited their access to consults and tools, and the number of submissions per reviewer has nearly doubled. Submissions without a clear narrative or organized structure make it harder for reviewers to engage.
The result? Vague feedback, delays, and missed opportunities. Well-structured, reviewer-friendly submissions with clear goals have a clear advantage: enabling reviewers to respond effectively and build trust. To get there, you have to start with the right questions.
Start with the questions, not the data
Many companies compile data without first asking what they want to learn from the FDA. This often produces irrelevant paperwork and limited feedback.
Focused submissions flip the script: What decisions are we trying to de-risk? What do we need from the FDA? Purpose matters more than volume. The FDA’s 2025 Q-sub guidance emphasizes a question-driven structure and encourages sponsors to work backward from the desired feedback. A submission built around clear questions will more likely yield helpful instruction.
[Image courtesy of the FDA]
Two ways submissions miss the mark
Submissions usually fail in one of two ways: too little or too much information. Too little detail causes disengagement or vague feedback like, “can’t offer an opinion,” and may paint an inaccurate picture about the product to reviewers.
The other extreme is including everything: irrelevant data, full QMS, or cybersecurity plans that do not address the regulatory question of whether the product is safe, effective and similar to its predicate. Data dumps obscure what matters and increase the risk of irrelevant feedback.
The FDA’s 2023 guidance on real-world data is clear. Data must be relevant, reliable, and directly tied to the question. Every piece of content must help reviewers make their determination, not market the product.
The product description is not a marketing document
Product descriptions are one of the most misunderstood sections of a submission and a common source of irrelevant or insufficient information. Many companies copy investor or sales materials, but what the FDA really needs is a detailed, functional walkthrough of how the product works, who uses it, and each step in its use.
A strong product description lays the foundation for meaningful regulatory conversation. For the FDA to comment on regulations, reviewers must understand what the product is. A vague summary won’t cut it. A well-written description can also be reused for future pre-submissions and market clearance processes if the product remains unchanged over time.
The consequences of a vague product description can be subtle. No alarm will sound, but feedback based on an incomplete understanding can cause problems later.
Say what you mean
It can be tempting to provide irrelevant information and write like a scientific journal author, but overly technical language slows and complicates reviews. Dense submissions may push reviewers to rely on AI tools to parse them.
Plain language supports efficient, AI-assisted review, helping reviewers use tools they already have. Plain language isn’t dumbing it down. It’s smart regulatory design.
Clarity is also about telling a story. Build a case that’s easy to follow, making it simple for reviewers to draw on every piece of information needed to answer your question. In return, you’ll get the guidance you need.
Use optional tools to de-risk your submission
Several tools can help sponsors mitigate risk in premarket submissions. Informational Q-sub meetings are helpful for novel technologies, allowing informal input before a full submission and clarifying FDA priorities.
Predetermined change control plans (PCCPs) are valuable for AI-enabled devices. Rather than rolling future changes into a 510(k) and risking rejection, sponsors can outline their evolution plan and seek early feedback. With few cleared PCCPs, work with the FDA before including one in a submission. For the right product, they can reduce future delays and submission costs.
The FDA’s new Regulatory Accelerator offers resources for sponsors, including guidance about requesting an early orientation meeting during a premarket submission. These meetings let sponsors demonstrate their product to assigned reviewers and answer early questions. Understanding a product g is central to success, so sponsors should take every opportunity to help reviewers understand.
Avoid the “I can’t comment” trap
Few things are more frustrating than waiting 70 days for FDA feedback only to hear, “I am not able to comment at this time.”
This usually results from unclear questions or poor context, as the FDA can only respond to what’s clearly asked and supported. If the product description is vague or the regulatory question poorly framed, reviewers are limited in their response. Once written feedback is issued, the follow-up meeting can only address those same topics, leaving little room to reframe and get a full answer.
A strong pre-submission is a strategic tool. When reviewers are stretched thin, submission quality shapes the experience. Thoughtfully structured documents signal regulatory fluency and help the FDA work efficiently, eliciting more valuable feedback, higher success rates, stronger trust and a smoother experience for everyone.
Acacia Parks is an advisor to Lindus Health and the founder of Liquid Amber, a consulting firm that guides digital therapeutics (DTx) companies and investors on scientifically and regulatory complex products across therapeutic areas including cancer, obesity, depression, Alzheimer’s, anxiety, ADHD and chronic disease. Parks previously served as chief science officer at Twill (formerly Happify) for a decade and as chief behavioral health officer at Found, a weight loss telemedicine company.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
