A Strategic Guide to the Q-Sub             

Pre-Submission Process

Early FDA Engagement for Medical Device Startups

For many medical device entrepreneurs, the FDA can feel like a looming hurdle that sits far in the future, something to deal with only once the technology is mature and funding is secured. In reality, early engagement with the FDA can be one of the most strategic moves a startup makes, especially when done through the FDA’s Q-Sub (Pre-Submission) process.

Rather than slowing innovation, early FDA interaction can clarify expectations, reduce risk, support fundraising, and set the tone for a collaborative relationship that lasts throughout the product lifecycle. For first-time founders in particular, the Q-Sub process is an underutilized tool that can significantly improve the odds of regulatory and commercial success.

What Is the Q-Sub Pre-Submission Process?

The Q-Sub program allows medical device developers to formally request feedback from the FDA before submitting a marketing authorization application for a novel medical device such as a 510(k), De Novo, or PMA. Although not required statutorily, it should be considered a requirement prior to initiating a clinical study, especially those requiring IDE approval. 

The Pre-Submission is typically a written document with specific questions for the agency and supporting context that is accompanied by a 1 hr teleconference meeting. This meeting can also be had in person at Silver Spring, MD. The ability to engage FDA face to face allows companies to ask specific questions in a collaborative engagement and receive nonbinding but highly informative FDA feedback.

Common topics for a Pre-Submission include:

• Device classification and regulatory pathway
• Predicate device strategy or De Novo considerations
• Nonclinical and clinical testing expectations
• Software, cybersecurity, or AI considerations
  

The goal is not approval, but alignment. A well-prepared Q-Sub helps ensure that when you do submit, you are answering the questions the FDA will ask during the marketing authorization review..

How Early FDA Engagement Clarifies Regulatory Requirements

One of the biggest risks for early-stage device companies is building the “wrong” evidence. Startups often invest significant time and capital into testing, documentation, or design decisions that later turn out to be misaligned with FDA expectations.

Early FDA engagement helps reduce this risk by:

• Confirming the appropriate regulatory pathway before major investments are made
• Clarifying whether a predicate strategy is viable or if a De Novo is more appropriate
• Aligning on the scope and rigor of verification and validation activities
• Identifying potential red flags early, when they are cheaper and easier to address

This clarity allows teams to plan development activities with greater confidence, avoid unnecessary rework, and make more informed tradeoffs between speed, cost, and risk.

How the FDA Q-Sub Process Strengthens Investor Confidence

Investors may not be regulatory experts, but they understand regulatory risk. A vague or overly optimistic regulatory plan can be a major concern during diligence, particularly for first-time founders.

A completed Q-Sub can strengthen your fundraising narrative by demonstrating that:

• You have engaged directly with the FDA
• Your regulatory assumptions have been reviewed and discussed
• Key aspects of your development and testing strategy have been informed by FDA feedback
• You are proactively managing regulatory risk rather than deferring it

While FDA feedback is nonbinding, the ability to say “we discussed this with the FDA and received feedback” carries real weight. It signals maturity, credibility, and disciplined execution, all qualities that investors look for when evaluating early-stage companies.

How FDA Pre-Submission Meetings Improve Strategic and Technical Decisions

Early FDA input does more than guide regulatory submissions, it influences core business and technical decisions.

For example, a Pre-Submission may inform:

• Whether to pursue a narrower initial indication to simplify clearance
• How much clinical data is likely to be required, if any
• Whether software features or AI claims increase regulatory complexity
• How design controls, risk management, and usability work should be scoped

These insights can shape product roadmaps, hiring plans, timelines, and even go-to-market strategies. In many cases, early FDA engagement helps startups avoid overengineering their first-generation product while still meeting regulatory expectations.

Establishing an Early Collaborative Relationship With the FDA

Contrary to common perception, the FDA is not an adversary. FDA is encouraged by industry’s desire to collaborate and their radar for punitive enforcement is aimed at manufacturers who choose to forgo FDA engagement. The Q-Sub process is designed to encourage early, transparent communication and to support the development of safe and effective medical devices.

Engaging early helps set the tone for a collaborative relationship by:

• Demonstrating openness and willingness to seek feedback
• Building familiarity with your technology and intended use
• Establishing a professional, respectful communication dynamic
• Reducing the likelihood of surprises later in formal review

This relationship becomes especially valuable as products evolve, indications expand, or post-market questions arise. Companies that engage early often find later interactions more efficient and productive.

Timing Matters, But Early Does Not Mean Premature

A common concern is engaging the FDA “too early.” While a Pre-Submission should be thoughtful and well-prepared, it does not require a finished design or complete test data.

Good candidates for early engagement typically have:

• A defined intended use and target patient population
• A clear concept of how the device works
• Preliminary thoughts on regulatory pathway and testing strategy
• Specific, well-framed questions for the FDA

The key is preparation. A focused Q-Sub with clear questions is far more effective than a broad request for general advice.

A Strategic Tool, Not a Checkbox

The Q-Sub Pre-Submission process is not just a regulatory formality. When used strategically, it is a powerful planning, risk-reduction, and communication tool.

For medical device entrepreneurs navigating limited resources, tight timelines, and high uncertainty, early FDA engagement can:

• Reduce costly missteps
• Improve development efficiency
• Strengthen investor confidence
• Support better long-term regulatory outcomes

Engaging early does not slow innovation. In many cases, it accelerates it by ensuring that teams are building the right evidence, in the right way, at the right time.

For startups serious about bringing a medical device to market, the question is not whether to engage with the FDA early, but how to do it thoughtfully and strategically.