Navigating the U.S. FDA regulatory landscape can be challenging, especially without early feedback. That’s where FDA Pre Submission support becomes crucial. At Elexes, we help you leverage the FDA’s Pre-Sub (Q-submission) program to gain critical insights before you file your official submission. Whether you’re developing a novel Class II device or preparing for a De Novo, our experienced regulatory team ensures you ask the right questions and present the right data to the FDA at the right time.
With a proven track record across 510(k), De Novo, PMA, and IDE submissions, Elexes prepares you for productive FDA interactions that save time, money, and frustration.
The FDA Pre Submission, also known as Pre-Sub or Q-submission, is a voluntary opportunity to engage with the FDA before submitting formal applications like 510(k), IDE, PMA, or De Novo. It allows sponsors to:
⦿ Request FDA feedback on planned studies or test protocols
⦿ Clarify regulatory pathways
⦿ Discuss submission format and expectations
⦿ Reduce the risk of major deficiencies in the actual submission
By engaging in Pre-Subs, companies can de-risk their product development process and ensure regulatory alignment early on.
Elexes offers a comprehensive suite of FDA pre-sub services tailored to your product type, risk class, and target regulatory pathway. Our services include:
⦿ Regulatory gap analysis
⦿ Drafting Pre-Sub questions
⦿ Identifying the most impactful FDA feedback areas
⦿ Authoring the Q-sub cover letter and package
⦿ Aligning content with FDA guidance
⦿ Data presentation and formatting
⦿ Meeting request and scheduling
⦿ Pre-meeting rehearsals
⦿ Real-time participation in FDA meetings
⦿ Post-meeting minutes and follow-up strategy
We’ve helped numerous startups, mid-sized manufacturers, and multinational firms improve their FDA approval timelines by starting strong—with the right Pre-Sub.
No two FDA submissions are the same—and neither should be your Pre-Sub approach. At Elexes, we customize every FDA Pre Submission strategy based on the nature of your product, its risk profile, and its intended use. Here’s how we help across five key product categories:
Early FDA input on substantial equivalence, performance testing, and labeling to avoid costly deficiencies later.
Strategic feedback on clinical protocol design, statistical analysis plans, and long-term performance endpoints.
Assistance with study protocols, risk classification, and regulatory pathways under 21 CFR 809 and CLSI standards.
Clarifying software function classification, cybersecurity documentation, and real-world data acceptability.
Pre-Sub strategies aligned with both CDRH and CDER or CBER, depending on your product’s primary mode of action.
What sets Elexes apart is not just our deep knowledge of FDA regulations—but our ability to translate that knowledge into actionable, customized strategies. Our consultants include former FDA reviewers, experienced engineers, and quality experts with real-world insight into what the FDA expects during the Pre-Sub process.
Whether you’re looking to discuss biocompatibility, clinical study design, software validation, or performance testing, we ensure your Pre-Sub is focused, persuasive, and effective.
With Elexes, you’re not just preparing for a meeting, you’re preparing for success.
A well-planned FDA Pre-Sub (Q-Sub) meeting can significantly reduce risks and accelerate device approval. See the difference our expert approach makes compared to skipping the Pre-Sub process.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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