How to Prepare for a Successful FDA Pre-Submission Meeting
The FDA Pre-Submission (Pre-Sub) meeting is a valuable opportunity for medical device startups to receive early feedback before submitting a regulatory application. Proper preparation can streamline the approval process, reduce delays, and improve your chances of success.
1. Understand the Purpose of a Pre-Sub Meeting
A Pre-Sub meeting allows companies to engage with the FDA before filing a 510(k), De Novo, PMA, or IDE application. The primary goals include:
✔️ Clarifying regulatory requirements
✔️ Receiving feedback on testing plans and clinical protocols
✔️ Reducing uncertainties in the submission process
2. Determine If You Need a Pre-Submission Meeting
Not all devices require a Pre-Sub, but it’s beneficial if:
🔹 Your device involves novel technology or lacks a clear predicate
🔹 You have questions about regulatory classification
🔹 You need feedback on clinical study design
3. Prepare a Strong Pre-Sub Package
Your Pre-Submission request must include:
📌 Cover Letter – Clearly state the purpose of the meeting
📌 Device Description – Provide details on intended use, technology, and risk classification
📌 Regulatory Strategy – Outline your planned submission pathway (510(k), De Novo, PMA)
📌 Specific Questions – Ask targeted questions to maximize the value of FDA feedback
📌 Clinical or Performance Data – If available, include relevant test results or study designs
📅 Submit your package through the FDA eCopy and Q-Sub system at least 70 days before your preferred meeting date.
4. Set Clear Objectives for the Meeting
To make the most of your discussion with the FDA:
✔️ Be specific with your questions – Avoid open-ended or overly broad inquiries
✔️ Listen actively – Take notes on FDA feedback for future submission planning
✔️ Clarify any concerns – Ensure you fully understand the agency’s guidance
5. Follow Up After the Meeting
After the Pre-Sub meeting:
🔹 Review meeting minutes and confirm key takeaways
🔹 Adjust your regulatory strategy based on FDA feedback
🔹 Prepare for next steps, such as additional testing or refining your submission
Conclusion
A well-prepared FDA Pre-Submission meeting can reduce regulatory hurdles, saving time and resources during the approval process. By submitting a strong package, asking the right questions, and implementing feedback, medical startups can streamline their pathway to market success.
About The Author
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
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