By Naghmeh Nouri, with Nicole Harada contributing
FDA is running on tighter resources than it has in years and doing a most admirable job adhering to the Medical Device User Fee Amendment (MDUFA) performance goals. Programs designed to accelerate review, including Breakthrough Device Designation, were experiencing longer queues at the end of 2025 and are experiencing increasingly stringent evidentiary requirements, some based on clarified interpretation of the scientific policies as the technology evolves. Some sponsors are responding by bypassing pre-submission (pre-sub) meetings entirely and proceeding directly to their marketing submissions, particularly 510(k)s.
Every week, a founder tells us they don't need to engage with FDA at all. They are confident in their regulatory pathway. Their contract manufacturer says they're fine. They want to move.
In the current regulatory environment, that confidence carries more risk and greater potential expenses than it did even 12 months ago. What you bring to a pre-sub is directly proportionate to what you'll get out of it, and at what speed. Walking in unprepared is more costly than it has ever been. So is bypassing the meeting when your submission warrants one.
A reasonable read of the current environment is that the agency's patience for wasted reviewer time has thinned in step. Sponsors who walk in with vague or underdeveloped questions, risk being perceived as underprepared. That is not a position you would want to be in, given the agency’s resource constraints and likelihood you will be working with the same reviewers again throughout your product’s regulatory lifecycle, and an unproductive use of your team’s time, your consultant’s time and the agency’s review time.
That dynamic makes the pre-sub more valuable, not less. A well-prepared pre-sub remains the single most effective tool available to sponsors for de-risking a marketing submission before committing to the full review cycle. The inverse is equally true, a poorly prepared pre-sub is now a more expensive form of feedback than it used to be, and bypassing one when your submission may need it, can set a program back by years.
There are circumstances in which engaging FDA prior to filing is not a strategic preference, it is a submission critical requirement. The four scenarios below come up repeatedly in our work because each represents a discrete point of failure capable of derailing an entire marketing submission. They are not the only reasons to engage FDA before you file, but they are the ones sponsors frequently underestimate.
If your preclinical protocol still has open questions. FDA expects sponsors to come to a pre-sub with a defensible draft preclinical study design. If you cannot fully justify your animal model selection, sample size, primary and secondary endpoints, or follow-up duration against applicable standards and guidance documents, align the protocol with FDA before initiating the study. The cost of executing a pre-clinical study that FDA subsequently determines insufficient to support your submission is measured in months and millions, not in pre-sub preparation time.
If your human factors plan isn't airtight. User group selection, critical task identification, and use environment representation are amongst frequent sources of FDA deficiencies in submissions with human factors. If you're combining user groups, have not correctly identified the relevant user populations, are excluding foreseeable edge cases, or are planning summative usability testing in an environment that does not adequately represent actual conditions of use, those are precisely the choices a pre-sub is designed to surface. FDA will not flag these deficiencies during substantive review, they will issue an Additional Information Needed Notification (AINN) or a Not Substantially Equivalent (NSE) determination and will stop reviewing your marketing submission.
If your pathway, classification, or predicate isn't fully settled. Predicate selection is where we see the most preventable damage. Sponsors arrive confident they have identified the appropriate predicate device, only to learn during review that FDA expected a different primary predicate, or that the device warrants a De Novo Classification Request rather than a 510(k), and has been incorrectly classified from the outset . A pre-sub is where you align with FDA on classification, primary predicates and reference devices, the basis of substantial equivalence, and the performance testing requirements that follow before you have committed your testing budget and associated protocols to the wrong regulatory target.
If your clinical synopsis hasn't been pressure-tested. If a clinical study is anywhere on your development roadmap, your synopsis needs FDA's review of the proposed endpoints, patient population, sample size, follow-up duration before you enroll. A sponsor we recently engaged walked into their first pre-sub planning to enroll fewer than 100 subjects. FDA's response was unequivocal; enrollment needed to be at least double that figure. Receiving that feedback before enrollment cost weeks. Receiving it after enrollment would have cost years.
Your specific situation may not map neatly onto one of these four scenarios and that is precisely the kind of question worth working through before scheduling the FDA meeting, not after.
The behavior FDA reviewers find most consistently unproductive is sponsors asking the agency to perform their analytical work for them. Questions such as, "Which indication should we pursue?" or "Do we need a clinical study?" signal that the sponsor has not prepared adequately. FDA expects sponsors to arrive with a well-supported position and a defensible rationale, then ask whether that position withstands scrutiny.
Think of it as a business school case study. The reading was assigned yesterday. You come to class today having worked through it, and the professor's job is to tell you whether your analysis was sound. The professor's job is not to do the case study for you in real time while the rest of the room waits. FDA approaches pre-subs the same way.
For the longer view on how to phrase the questions you do bring, read the companion blog to this piece: Mastering the Pre-Submission Strategy: What to Ask (and Never Ask) the FDA About Human Factors.
First, every regulatory position you bring is supported by evidence you can substantiate, primarily literature, applicable FDA guidance documents and a documented analytical rationale. If your regulatory partner is providing direction without citations, without a thorough review of the applicable evidence and without a defensible analytical basis, that is the signal to slow down.
Second, your strategy has been stress-tested with more than one expert. You would not proceed with major clinical intervention on the basis of a single physician's assessment without seeking a second opinion. The same principle applies here, with one important distinction. The most efficient version of a second opinion is not a second consulting engagement. It is an integrated multi-disciplinary team that brings regulatory affairs, clinical research, human factors engineering, biostatistics, and quality system specialists into a unified review, without requiring you to coordinate handoffs between vendors. Engaging multiple firms introduces multiple invoices, separate NDAs, IP exposure risks, competing timelines, and the absence of a single accountable party when a gap is identified. A large CRO, a boutique consultancy, or an independent specialist can each provide a regulatory perspective. What they cannot always provide is a human factors engineer with the technical depth to develop your human factors plan as an integrated component of the same pre-sub without engaging a different entity.
Third, you have determined which questions belong in the pre-sub and which do not. Questions answered by an applicable standard and FDA document, or a well-selected predicate device do not belong in front of FDA. They belong with your team and your data. The pre-sub is reserved for the clarity only FDA can provide. The strongest questions for an FDA re-sub yield discrete binary answers: agree or disagree.
Think of Veranex as your pre-submission consultation, the critical preparation step before the FDA meeting. Before you bring questions to FDA, we help you determine which ones merit a formal response and which we can resolve with you first. Our regulatory team includes former FDA reviewers and senior leaders with decades of experience inside CDRH, working alongside clinical research, human factors engineering, biostatistics, and quality system specialists under a single roof. The regulatory strategy you present in your pre-sub has been pressure-tested across every discipline that will ultimately determine its outcome.
If you're weighing a pre-sub, planning one, or wondering whether you need one at all, that's the conversation to have with us. Contact the Veranex regulatory team to talk through where you are and what a well-prepared pre-sub looks like for your specific submission.
Full lifecycle compliance strategies that shape upstream decisions and streamline downstream review
Regulatory strategy developed in isolation from design, clinical, and commercial realities leads to misaligned submissions, avoidable questions, and costly delays. Regulatory Affairs provides strategic consulting and submission support across FDA (510(k), De Novo, PMA), EU MDR/IVDR, and international pathways integrated with Engineering & Development, Preclinical Services, Clinical Research, and Quality Consulting from the earliest stages of development. Upstream, our regulatory experts inform design inputs and align evidence generation with submission requirements before studies launch. Downstream, regulatory strategy shapes Medical Writing deliverables and post-market surveillance planning. Because our experts have shaped the evidence rather than inherited the documentation, they anticipate reviewer questions instead of reacting to them.
About the authors
Naghmeh Nouri is Executive Director of Quality and Regulatory for Veranex. In a strategic consulting role, she brings more than 3 decades of complex blend of regulatory acumen and business insight across the global medical device landscape including emerging technologies in cardiovascular devices, digital health, AI-driven solutions and various therapeutic medical devices. She partners with executive teams to translate complex regulatory requirements into integrated strategies that align with product development and commercialization goals. With a proven track record in design assurance, verification and validation, risk management, regulatory submissions, CE marking, QMS implementation, and post-market compliance, I also bring particular strength in process validation, outsourced manufacturing oversight, and collaboration with contract manufacturing organizations (CMOs). Her ability to balance strategic vision with operational execution and hands on experience, enables organizations to accelerate market access while maintaining the highest standards of quality and regulatory integrity and empower clients to scale with confidence.
Nicole Harada is a Senior Associate of Regulatory Affairs. Nicole joined Veranex (legacy Experien Group) in 2017 and has been with the company for about 8 years. At Veranex, Nicole drafts and reviews clients’ regulatory assessments and prepares documentation for U.S. regulatory submissions including Pre-Submissions, 510(k)s, De Novos, PMAs, IDEs, EFS IDEs, and Breakthrough Designations. Nicole supports team operations by managing project budgets, improving eSTAR and documentation processes, mentoring teammates, and creating new tools to streamline submission tracking and execution. Nicole also supports the business development team as a SME for regulatory on introduction calls and proposal/SOW drafting.