October 10, 2025

For medical device developers, one of the most important strategic choices is deciding when and how to engage with the U.S. Food and Drug Administration (FDA), as this decision can shape regulatory timelines, evidence requirements, and ultimately the success of market entry. The Pre-Submission (Pre-Sub) program is designed for exactly this purpose. A Pre-Sub falls under the FDA’s broader Q-Submission (Q-Sub) program, which establishes formal pathways for device manufacturers to seek feedback before or during development of regulatory applications such as Premarket Notification 510(k), Premarket Approval (PMA) or De Novo classification. Proactive use of a Pre-Sub helps sponsors clarify FDA expectations early, lowering regulatory risk, avoiding review setbacks, and accelerating patient access to new technologies.

Pre-Subs are particularly valuable because they allow sponsors to engage with FDA on important regulatory questions before committing significant resources to development or submission activities, ensuring that critical decisions such as study design, predicate selection, or testing strategy are aligned with regulatory expectations early. For example, a sponsor may request FDA’s perspective on whether a proposed predicate device is appropriate for a 510(k) submission, whether the design of an early feasibility study is adequate to support an Investigational Device Exemption (IDE), or whether cybersecurity testing plans are sufficient for a connected device. By confirming these elements in advance, device manufacturers can reduce the risk of major deficiencies being identified during the substantive review process.

At the same time, it is important to recognize what a Pre-Sub is not. A Pre-Sub does not constitute a formal review of an entire submission, nor does it provide binding regulatory decisions. Instead, it functions as a structured forum for dialogue, giving sponsors insight into FDA’s current thinking and helping them refine their development strategy accordingly. This distinction ensures that while sponsors gain clarity, they also retain flexibility to adapt their plans as new data or requirements emerge.

FDA has defined clear content requirements for a Pre-Submission request to ensure that sponsors provide sufficient context for FDA reviewers to deliver meaningful feedback. According to the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, a complete request typically includes a cover letter, sponsor and device information, information on the device’s proposed intended use, testing plans, and any regulatory history of prior FDA interactions for the product. Importantly, the guidance emphasizes that the quality and scope of questions drive the value of FDA’s feedback. Sponsors should prioritize a limited number of high-impact, targeted questions that address regulatory strategy, study design, or other areas of potential risk. Each question should be specific, well-supported by background information, and framed in a way that enables FDA to provide actionable feedback. Conversely, overly broad or generic questions, or those that could be answered by reviewing existing guidance documents, are unlikely to generate meaningful responses. This structured approach not only helps FDA prepare in advance but also ensures that sponsor feedback is focused, efficient, and directly relevant to the key regulatory decisions at hand. This structured approach helps FDA prepare in advance and ensures that feedback is both efficient and targeted.

While this traditional format remains the standard, FDA has recently introduced the PreSTAR template as part of its modernization efforts, aiming to standardize these same content requirements in a more consistent and user-friendly format. PreSTAR is a new template introduced by the FDA to standardize and streamline the format of Pre-Submissions. Its purpose is to align sponsor submissions with FDA’s internal review templates—improving the completeness, accuracy, and consistency of information provided during early regulatory interactions. At this stage, PreSTAR remains a voluntary pilot program, giving applicants the option to adopt the template while FDA evaluates its broader implementation.

The template covers key elements of a Pre-Sub, including submission type and purpose, sponsor details, product description, proposed indications for use, classification rationale, draft labeling, and the applicant’s targeted questions to FDA. Built-in features, such as required field indicators and embedded help text, are designed to minimize omissions and administrative errors. By providing a standardized structure, PreSTAR promotes higher-quality submissions, helps FDA deliver more efficient feedback, and offers applicants an added level of predictability in preparing for future regulatory milestones.

Benefits:

Pre-Submission interactions offer several strategic advantages to medical device developers. Early engagement allows sponsors to identify potential regulatory hurdles and refine study designs before they become costly issues, while also providing clarity on the data and documentation needed for a formal submission. By obtaining FDA’s perspective on key elements such as clinical protocols or predicate selection, sponsors can mitigate submission risks, reduce potential submission delays, and strengthen the overall quality of their submissions. These interactions also help build a collaborative relationship with the Agency, fostering more constructive communication during later reviews. For many start-ups and smaller sponsors, the insights gained from a Pre-Sub can be especially valuable for guiding resource allocation and aligning regulatory planning with broader business objectives.

Risks:

Although Pre-Submissions provide clear strategic advantages, they are not without challenges. Preparing a complete request and waiting for FDA’s feedback can extend development timelines, with the typical Pre-Submission process taking around 75 days. In addition, the feedback received may introduce unexpected requirements such as revised study protocols or additional testing that differ from the sponsor’s initial plan. While this can feel like a setback, it is far preferable to identifying such issues during substantive review, when the consequences of delay or rework are significantly greater.

In short, the benefits of Pre-Submissions generally outweigh the potential drawbacks. While the process requires time and may introduce additional requirements, early engagement with FDA reduces uncertainty, strengthens submission quality, and helps avoid far more costly setbacks later in development. By approaching Pre-Subs strategically, choosing the right timing, asking focused questions, and preparing effective briefing materials, sponsors can turn these interactions into a powerful tool for de-risking regulatory pathways and accelerating patient access to safe, effective medical technologies.

While the Pre-Submission program offers significant advantages, the quality of the interaction depends largely on how sponsors prepare for it. Poorly framed or premature Pre-Subs can result in limited guidance. To maximize the benefits of this process, sponsors should consider several best practices when planning and executing their Pre-Submission request.

• Timing matters: A Pre-Sub is most valuable once the device’s intended use and description are well defined and high-risk regulatory questions have been identified. If the intended use or core design elements are still uncertain, FDA will have little basis to provide meaningful feedback.
• Ask the right questions: Sponsors should focus on questions that address regulatory or clinical risk, such as predicate selection, clinical study design, or design inputs. Each question should be specific, supported by sufficient context, and framed in a way that allows FDA either to agree with the sponsor’s approach or to propose an alternative. Broad or unsupported questions rarely lead to actionable feedback.
• Prepare an effective briefing package: The submission should provide enough detail to justify the proposed approach while avoiding unnecessary background that distracts from key issues. Using FDA terminology and citing relevant guidance documents demonstrates alignment with regulatory expectations and helps FDA reviewers provide more focused responses.

By applying these practices, sponsors can ensure that the Pre-Submission process delivers meaningful feedback that strengthens both development and regulatory strategy.

The Pre-Submission program remains one of the most practical tools available to medical device developers. By engaging FDA early, sponsors can gain clarity on regulatory expectations, strengthen their evidence strategy, and avoid the costly delays that often arise from unforeseen deficiencies during substantive review. While the process requires careful preparation and introduces some additional time to development, this effort and time is typically far outweighed by the long-term benefits of reduced uncertainty, improved submission quality, and more predictable review outcomes. As FDA continues to modernize the program through initiatives like PreSTAR, device manufacturers that incorporate Pre-Subs into their regulatory planning will be better positioned to bring safe, effective, and innovative technologies to market.

Anand Bhati

Regulatory Specialist

Anand Bhati is a Regulatory Specialist at Accorto Regulatory Solutions with experience in regulatory submissions, risk management, and global compliance for medical devices. He holds a Master’s in Regulatory Affairs from Northeastern University. His experience includes supporting 510(k) submissions, risk assessments, and regulatory strategy development for medical devices. He has contributed to post-market surveillance initiatives, clinical compliance tools, and vigilance reporting, ensuring adherence to FDA and international regulations. With a strong focus on cGMP compliance and quality systems, Anand is committed to regulatory excellence and facilitating market access for healthcare innovations.

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