What is a Pre-submission (FDA) and why should manufacturers use it before filing a 510(k) or De Novo?
- SANRUBIO, LLC
- Jul 29
- 2 min read
The FDA Pre‑Submission (Pre‑Sub) process is a strategic tool under the FDA’s Q‑Submission Program that allows medical device manufacturers to receive formal, written feedback from the agency before submitting regulatory filings such as a 510(k) or De Novo request.
This written feedback can cover topics like regulatory strategy, non-clinical and clinical testing approaches, predicate selection, and more. While the FDA’s response to a Pre‑Sub may or may not be considered binding in future submissions, it provides valuable scientific and regulatory guidance to sponsors.
🎯 key benefits of the FDA Pre‑Submission (Pre-sub)
Reduced regulatory risk: helps identify potential gaps or misalignments in the submission approach before committing to a full dossier.
Saves time and resources: written FDA input clarifies expectations and reduces the likelihood of additional information requests or rejections later in the process.
Greater technical clarity: confirms early decisions related to testing methods, clinical endpoints, and validation strategy.
⏱️ what’s the timeline of the FDA Pre-submission?
Once a Pre‑Sub is accepted, the FDA typically provides written feedback within 70 calendar days.
Sponsors may request a meeting or teleconference, but this is optional. many manufacturers opt for written feedback only.
ℹ️ what a Pre‑Sub is not
The FDA Pre-submission does not replace a formal review or automatically expedite a 510(k) or De Novo.
It does not serve as an FDA approval or a definitive regulatory decision.
The FDA’s feedback in a Pre‑Sub may or may not be binding, and should be considered an early advisory opinion only.
🤝 How Sanrubio, LLC supports you
At Sanrubio, LLC, based in Miami, we offer:
Tailored regulatory consulting: From pre-submission planning to 510(k) or De Novo submission preparation.
Strategic location: Miami serves as a gateway for international manufacturers entering the U.S. market.
Free consultations: Discuss your project with our experts and optimize your regulatory pathway.
Ready to bring your medical device to the U.S. market?
CONTACT US for personalized consulting and take the next step in your medical device journey with confidence
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