FDA Pre-Submissions, a type of Q-Submission, allow you to engage the FDA early, obtain feedback on specific questions, and refine your regulatory pathway. At Elexes, we help you make the most of this valuable opportunity by preparing persuasive, structured Pre-Sub packages and facilitating productive interactions with the FDA.
Whether you're working on a novel Class II device, SaMD, or PMA product, our team of FDA Pre-Submission consultants guides you from strategy through submission.
Let us help you ask the right questions before it's too late.
FDA Pre-Submissions provide a platform to clarify regulatory expectations prior to submitting your 510(k), De Novo, or PMA application. FDA Pre-Submissions are voluntary and can be particularly useful for complex or novel technologies where feedback could inform testing, clinical studies, or submission planning.
Our FDA pre-submission consultants will assist in the preparation of a concise list of technical, clinical, and regulatory questions with the rationale and supportive evidence. We assist with:
⦿ Meeting requests and briefing packages
⦿ Clarification of testing or clinical study requirements
⦿ Regulatory strategy refinement
⦿ SaMD FDA Pre-Subs and cybersecurity considerations
⦿ Companion diagnostics (CDx) and IVD Pre-Subs
Our Pre-Submission documents align with the latest FDA guidance on Q-Submission Program, ensuring your message is complete, concise, and clear.
⦿ Pre-Sub strategy development tailored to your device type and regulatory path
⦿ Clinical and nonclinical questions framing and justification
⦿ Drafting and formatting of FDA Pre-Submission documents
⦿ Submission to CDRH, CBER, or appropriate FDA office
⦿ Meeting preparation, coordination, and rehearsal following review of FDA’s written feedback
⦿ Post-feedback review and regulatory action planning
This comprehensive approach ensures your FDA Pre-Submission is not only complete but impactful.
Our regulatory experts collaborate with clinical, R&D, and quality teams to craft robust Pre-Submissions across device categories including diagnostics, software, combination products, and implantables.
We don’t just prepare documents, we advise on the optimal timing, questions to ask, and how to phrase them to align with FDA expectations and avoid rejections.
From 510(k) pre-submission to PMA, SaMD to IVDs, we’ve handled Pre-Submissions for diverse technologies, helping clients avoid costly missteps later in development.
We review FDA Pre-Submission packages against the applicable Pre-Sub Acceptance Checklist or PreSTAR technical-screening requirements, depending on the submission format.
Our team helps you incorporate FDA feedback into testing plans, labelling, and subsequent submissions, supporting informed development and regulatory decisions.
Make informed decisions with visual clarity. This infographic illustrates how a Pre-Submission fits into your FDA journey and what to expect at each step.
Let Elexes guide your FDA Pre-Submission and help you gain clarity, confidence, and compliance from Day 1.
No. FDA Pre-Submissions are voluntary. They are useful when feedback on specific questions could influence development, testing, or submission planning.
FDA targets written feedback within 70 calendar days from the review-clock start. If a meeting is requested, feedback is targeted at least five days before the meeting and no later than day 70. Meetings are typically scheduled around days 70–75 by mutual agreement. Holds can affect timing.
Complex, novel, AI/ML-based or software-based devices benefit the most. It helps clarify testing, clinical, or classification uncertainties early on.
Yes. Our FDA pre-submission consultants can take part in the discussion along with you or represent you upon agreement.
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.
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